Category Archives: Rational Drugs

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Generic Dava – Isse Behtar Kuchch Nahi…

DainikBhaskar

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Open letter to DG, WHO – Pentavalent vaccine related deaths in India

To

Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 2012

Draft National Pharmaceuticals Pricing Policy (NPPP-2011) & response

The Draft National Pharmaceuticals Pricing Policy (NPPP-2011) has been released. View it here.

A brief comment on the NPPP-2011 was written by AIDAN member Srinivasan S. and published in The Hindu Business Line, November 8, 2011

Pharma industry gets away lightly

The draft National Pharmaceuticals Pricing Policy (NPPP-2011) declares that all 348 essential medicines (as per the new National List of Essential Medicines, NLEM 2011) will be under price regulation. The shift in focus from market share to whether medicines are essential is to be welcomed. However, the policy still leaves scope for non-essential and irrational medicines to be made. It also has made calculating ceiling prices of the many medicines not in NLEM a tedious, if not impossible, exercise.

In addition to the NLEM 2011, top selling 300 medicines of the IMS could have been covered. The draft policy delinks the ceiling prices of formulations from the price of bulk medicines. Indeed, the arguments given in the draft policy for removing price control of bulk medicines do not make sense. The government should have kept the option of price control on bulk medicines in the event of cartelisation or abnormal increases in price of bulk medicines.

The latter may result in the scarcity of a particular essential medicine formulation unless it is already overpriced relative to the cost of the bulk medicine used. Worse, this may result in the bulk medicine or the formulation not being made within the country.

Secondly, using the WPI (Wholesale Price Index) to revise prices is not a good idea. It adds an inflationary element to the ceiling price automatically every year. The WPI (100 for base year 2004-05) for 2010-11 is 143.3. Most medicine prices have not really increased 43 per cent during the period. It would have made sense to have the ceiling price of a medicine formulation tied directly to the related bulk medicine price increase during the year.

RELIANCE ON MARKET

The arguments for totally relying on market-based pricing (MBP) of formulations apparently do not recognise the fact that there exists a wide range of prices in the market of the same formulation and that prescribers, and therefore patients, tend to place more value on the costlier brands of the same formulation. In medicines, unlike say soaps or cars, the brand leader is also the price leader. The proposals of market-based pricing, therefore, legitimise higher prices. The key para in the draft policy is para 4.7: “The Ceiling Price would be fixed on the basis of Weighted Average Price (WAP) of the top three brands by value (MAT value) of a single ingredient formulation medicine from the NLEM on per standard dosage basis.”

The WAP idea means that it will end up legitimising high prices, especially if the top three brands are overpriced: top selling brands — with a few exceptions — would be the costliest.

That is the norm of the medicines sector, thanks to asymmetry between consumer and prescriber/manufacturer. It means that that regardless of overpricing and profiteering, if the market “accepts” it, the price is ok. Never mind if the patient may get poorer in the process. It also legitimises the mistaken notion that higher priced medicines are of better quality. In our case, for example, albendazole selling above Rs 12-13 per tablet (price of current market leaders) would seem fine.

A comparision of medicine prices

A comparision of medicine prices

Ceiling prices need to have a clear relationship with the cost of the raw material at least. The WAP formula has, in effect, no relation with the cost of raw material, let alone the cost of other inputs. The MRP to raw material ratio is about 3000-5000 per cent in quite a few essential medicines. Should a government legitimise such super profits? Most retail pharmacies do not keep cheaper versions because of lesser margins; eventually all lower-priced brands will move towards the higher ceiling price even as ‘premium’ prices, including that of overpriced imported medicines such as Novartis’ Glivec, will take a hit with the WAP formula.

MEDICINES OUTSIDE NLEM

The draft policy gives a formula to discourage non-standard dosages. The same thinking could have been applied to discourage irrational and unscientific medicines outside the NLEM. One can discourage irrational combinations, and attempts to circumvent the ceiling price, by taking the cue from the Pronab Sen Task force Report — from which many of the recommendations have been taken anyway — which says, “For formulations containing a combination of a medicine in the NLEM and any other medicine, the ceiling price applicable to the essential medicine would be made applicable.” Sales tax and excise duty could be higher for medicines outside NLEM 2011 and zero for NLEM medicines. The draft policy could also take another recommendation from the Pronab Sen Committee: debrand, that is remove brand names, to ensure true competition among generics.

The draft policy lists certain exemptions which, again, are inexplicable: all medicines costing less than Rs 3 per unit are to be exempt. This again legitimises overpricing of medicines which cost 10-20 paise, and begs them to be priced near Rs 3. An example is cetrizine, which costs less than 15 paise per tablet to make, but the brand leaders are available near Rs 3. Why should this be condoned? Should much-needed iron plus folic acid tablets, which cost less than 10 paise per tablet to produce, be given leeway to sell at or near Rs 3? Most retailers will give only a strip of 10, even when one needs a couple of tablets only.

THE ALTERNATIVE

So, what is a better pricing policy? That will be one that brings down the prices of overpriced medicines; that has some linkage to the actual cost of production, and therefore to the cost of the raw material; and does not legitimise overpricing of medicines. Nominally reducing the price of the top-selling brand is tokenism.

A good starting point would be to take as reference price the prices of well-run public procurement systems and take a multiple, say 4 to 6, of the reference price as the ceiling price. The present WAP procedure will make the ceiling price 20 to 70 times the public procurement price — which is a little rich.

The draft policy gives the impression of a policy cobbled to satisfy perfunctorily the Supreme Court Orders of March 2003 and October 2011, one that will leave major players mostly unaffected. A policy with some bark and a little bite.

(The author is associated with the All-India Drug Action Network and LOCOST, Vadodara. blfeedback@thehindu.co.in)

(This article was published on November 8, 2011)

Ensuring affordability, accessibility and safety of medicines through urgent action

Health Action

Health Action

Health Action (HA) has published articles relating to essential medicines, generic medicines, drug price control and other drug related issues in its September 2009 issue. Some of the relevant articles have been uploaded here (with permission from HA).

Dubious Rather Than Spurious Drugs – India’s Real Drug Problem
Dr Anurag Bhargava M D

Access to medicines implies access to medicines of proven efficacy, safety and acceptable quality, prescribed in a rational manner. Governments have a responsibility of ensuring availability and affordability of such medicines. Yet the situation in India with all these issues related to medicines is marked by paradoxes. In spite of having one of the largest pharmaceutical industries supplying low-cost essential medicines globally, India has the largest number of people in the world without access to essential medicines, …………

People’s Initiative for Generic Medicines
Dr. Anant Phadke

In India, medicines are unnecessarily exorbitantly costly. Prices of medicines can be brought down to one half, even to one-fourth immediately, if the government takes appropriate measures to stop reckless profiteering and waste that are prevalent in the manufacture and sale of medicines. Since the early eighties, the All India Drug Action Network (AIDAN) has been advocating these measures, but in vain. While it may take many more years to change the govt…….

Essential Medicines: Economic constraints in access in India
Dr. Purnabrata Gun & Sushanta Roy

Essential medicines are among the most costeffective elements in modern health care and their potential health impact is remarkable. This year alone, there will be over 40 million deaths in developing countries, one-third among children under age five. Ten million deaths will be due to acute respiratory infections, diarrheal diseases, tuberculosis, and malaria. Safe, inexpensive, essential drugs can be life-saving in all these disease conditions……..

Good to be True, but True! Retail Sale of Generic Drugs at Low Prices by the Government in Chittorgarh Dt
S.Srinivasan

We all know that one of the solutions for making medicines affordable to people is to make available only essential generic drugs at lower prices, that is if your doctor prescribes them in the first instance. Procurement prices of generic drugs by Governments like that of Tamil Nadu and Delhi have revealed that prices of generics are 1.5 % to 10 % of the maximum retail price (MRP) of branded equivalents at the retail level. However, to get a retail pharmacist to stock these low-priced generics is easier said than done…..

Drug Price-Control: Problems, Principles and Prospects
Dr Chandra M Gulhati

One way or the other, prices of many sensitive goods and services are subject to some sort of price regulation either through state’s intervention or other mechanisms including competition, negotiated prices by bulk buyers, reimbursement by insurance companies just to mention a few…………

To download the entire issue of Health Action, September 2009 issue, click here

Rational Drugs

What is Rational Therapy?

Rational drug therapy means the use of drugs, which are efficient, safe, low-cost and easy to administer. It requires that health practitioners have adequate medical knowledge and appropriate skill for correct diagnosis and treatment. They would also be required to have time and concern for their patients.

Rational drug therapy thus is only part of the larger issue of rational treatment – which in turn is a subset of the large issue of rational health services. Rational health care implies rational diagnosis and treatment. Rational diagnosis means ordering the appropriate amount of procedures, laboratory test, X-ray, etc., not more, not less. Rational treatment also assumes rational behaviour by the patient after a medicine is prescribed provided he/she can afford it.

Rational means also appropriate

The Oxford English Dictionary defines “rational” as that which is based on reason, which is sensible, sane or moderate. Rational drug therapy may be used interchangeably with the concept of appropriate therapy, which may be described as ordering the appropriate right medicine for the right / appropriate indication, for the appropriate / right patent at the right time and in the right dose, route and duration, with due consideration of costs.

An appropriate Indication for the Use of Drugs should Exist.

·        A1 – year old with low body weight for age is seen in the OPD, because the parents noticed a pot belly. This is clearly due to under nutrition. The family is poor but the child not been weaned and given solid food till now. Should the child receive advice on feeding or an alcohol based ‘tonic’?

·        A chronic smoker comes with cough off and on, especially in the morning. There is no shortness of breath. The clinical examination is normal. Should he receive a cough suppressant, an antibiotic or advice and support for stopping smoking?

·        A child comes with viral upper respiratory infection (rather long and impressive name for a common cold) with a fever, running nose and a mild cough. Should he receive antibiotic like amoxicillin which would be useful only in bacterial infections, a syrup which has a combination of cough suppressant and cough expectorant (such preparations which are neither fish nor fowl but both abound in the market), or advice that the illness is a mild, a self-limiting one, where paracetamol can be used if the fever is significant?

·        A 2-year child comes with diarrhea with passage of 5-6 loose stools without significant abdominal pain or any blood. This is again likely to be only viral diarrhea, which like viral upper respiratory infection is self-limiting. Should he receive oral rehydration solution (even home-made ORS which is rice-based would be appropriate), or a combination of ciprofloxacin (a drug to be avoided in children under 14 years of age) and metronidazone (which is effective only in amebiasis, giardiasis)?

·        A computer professional has low-backache of long hours of sitting at the desk in a faulty posture on a faulty chair. Should he receive long term pain killers or advice on posture, exercises and a proper chair which supports the lower back?

·        A 24-year old married woman complaints of mild nausea in the morning. On enquiry her periods are overdue by 15 days. Should she receive drugs for nausea or an evaluation for pregnancy?

In each of the above examples which are very common in our experience, the use of drugs like tonics in under nutrition, cough suppressants in a chronic smoker without advice on smoking cessation, a drug for bacteria like amoxicillin in a viral infection, and use of irrational medications like combinations of antibiotics (ciprofloxacin and metronidazole) or combinations of cough suppressants and cough expectorants, are not indicated at all. The use of such drugs is in appropriate, leading to sub-optimal a care, a waste of resources, and endangering the health of the patients. The use of drugs like ORS, and simple antipyretics like paracetamol would however be termed appropriate or rational.

Not only do many conditions require No Drugs or Very few drugs, but Non-drug treatment is an important complementary treatment with drugs for many common diseases, e.g. weight reduction, smoking cessation, going low on fats in diet, is an important part of the management of diabetes, hypertension, and angina. Similarly eating high fibre diet, drinking lots of fluids, and exercising is important in treating constipation. And in many conditions some form of surgical intervention is indicated from bleeding piles, to gall-stones which are causing symptoms and complications, to cataracts. In all these conditions, drug therapy has no or a very limited place as a primary treatment.

Appropriate Medicine Should be Used: Is it the Right Drug for the Right Patient?

The drug to be used should be efficacious, safe and cost-effective, and suitable for use in a patient. Which are these drugs that we can rely on? Fortunately there is broad international and even national consensus on a limited number of essential drugs, which are efficacious, safe and cost-effective. These are the drugs contained in the lists of essential medicines. It is from these lists of essential medicines we can choose the right drugs for our patients. When we choose drugs from these lists, we are automatically choosing drugs with demonstrated efficacy, safety and cost-effective and practicing evidence drug therapy.

The list of essential medicines covers the right drugs of choice for treatment of priority disease conditions be it anemia, asthma, or diabetes, hypertension or epilepsy. How these drugs are to be used is described in textbooks of medicine, pharmacology. Also an increasing number of professional and public health related organizations bring out Standard Treatment Guidelines for treatment of particular disease conditions. Guidelines from WHO exist for treatment of TB, Leprosy, and other communicable and non-communicable diseases. In India, State level and National level guidelines for treatment of common disease conditions have been compiled, and need to be disseminated and used widely to realize their potential for providing rational, safe and cost-effective care.

Apart form making the correct diagnosis, choosing the right drug from the list of essential medicines and standard treatment guidelines, the suitability of the drug for the individual patient has to be assessed before starting the treatment. The drug should not only be right but be right for our patient. There are a number of factors which need to be taken into account by the prescriber. In fact all patients can draw the attention of their doctors to these factors while they receive their prescriptions.

There are three things which are absolutely essential to bring to the attention of the doctors. The first is any history of a possible reaction in the past. The second is the possibility of pregnancy in all women of child bearing age. Before accepting a prescription for any illness, a woman should keep this in mind. It is better to rule out pregnancy if monthly periods have been delayed, rather than take a drug unknowingly which can affect the development of a child permanently. The third is any   other illness that the patient has and the treatment that he is taking for the same.

Age is important consideration. Some drugs like tetracyclines are not safe in children. In the elderly the rate of breakdown of drugs is lower so that doses have to be lower and one has to be on the look out for side effects which are more frequent in this group. Pregnancy and lactation affect the choice of drugs in a major way, and women who are pregnant need to exercise particular caution about taking drugs. The individual patient may have allergy to certain commonly used drugs like pencillins and sulfonamides, which have to be therefore avoided. Coexisting illness often dictate the choice of drugs, e.g. a patient with hypertension and asthma should not be given a beta-blocker like propranolol which can worsen the asthma, which can otherwise be used in other patients with hypertension. Patients with diseases of liver and kidney need to be particularly cautious while using drugs, because most drugs can potentially cause side effects on the liver and kidney and worsen their condition. Even the occupation of the patient has to be taken into account. A drug for sneezing due to nasal allergy which can cause some drowsiness, would be completely unacceptable in an airline pilot or the driver of a super fast train.

We have discussed in the above paragraphs the selection of drugs from the list of Essential Medicines. What about the drugs which are available in the market and fall outside this list? Some of the drugs which are outside this list are of complementary drugs which are to be used in selected patients, under specific situations, in a specific healthcare setup, e.g. certain antibiotics for use in antibiotic resistant infections, or anti-cancer drugs to be used in a hospital setup for use in certain cancers. But a large number of drugs which are outside the list of Essential Medicines are simply more expensive alternatives for essential drugs, e.g. ramipril works on the same principle and to the same extent as enalapril which is an essential medicine for use in hypertension and heart failure, but is more than five fold in terms of cost tot patient. In fact a huge number of drugs, which do not figure in the list of Essential Medicines are in fact of dubious efficacy, rationale, safety, but are money-spinners for their companies. E.g. most preparations for iron deficiency anemia in this country do not conform to the criteria mentioned in the list of Essential Medicines.

Drugs have to be Administered in an Appropriate Dose at an Appropriate Interval through an Appropriate Route for an Appropriate Duration.

Sample the following:

·        A patient pneumonia admitted in a private hospital does not improve after 3 days of therapy with a “higher antibiotic”. He is receiving injection Cefotaxime 1g once a day.

·        A woman with high fever, discomfort while passing urine and flank pain was diagnosed as having an upper urinary tract infection. She was given an antibiotic in the correct dose and dosing interval but for 5 days. Improving initially, she developed recurrence of the same problem two weeks later.

·        A patient in a village in Chattisagarh has had recurrent episodes of malaria over the past months. During each such episodes the patient was administered injection Chloroquine 2 ml by an intramuscular injection daily for 3 days.

·        A patient suffering from persistent asthma of moderate severity has been on long-term oral medication with salbutamol and prednisolone.

Apart from selection of the appropriate drugs it is critical to ensure that the drugs are used in the proper dose, interval, and duration through an appropriate route. This is one area where there is a rampant anarchy in India of which the above is a small sample. The patient with pneumonia received an improper dose. The antibiotic given as 1 dose/day of a drug should have been administered 3 times in a day. The woman with the upper urinary tract infection was given the wrong duration of therapy. She needed to be treated for 14 days to eradicate the infection, yet was treated only for 5 days, which was the reason for the recurrence of the infection. The villager with malaria received the right drug through the wrong route. Chloroquine should have been administered through the oral route an in an appropriate dose 10 tables for 3 days.  The choice of injections was particularly inappropriate as chloroquine is one drug which is very well absorbed when taken  by mouth, and giving the injection led to massive under dosing as shown below.

Use of Injections of Chloroquine in Uncomplicated Malaria: An example of Massive Under Dosing.

An adult patient with malaria needs to be given a total of 1500mg of Chloroquine over 3 days.  Therefore the appropriate dose in terms of tablets is 10 tablets which is given in the schedule of 4-4-2, in the national antimalaria program. (4 tablets on day 1, 4 on day 2, 2 on day 3).

1 ml of Chloroquine injection on the other hand contains only 40mg of Chloroquine, which is nearly a quarter of the content of table. Therefore a patient who received 2ml injection daily for 3 days, received a total of 40 x 2 x 3 i.e. 240mg of Chloroquine, which is less than a total 2 tablets of Chloroquine and only 1.6 of those dose required for malaria.

Lastly the patient with persistent asthma received the improper dosage form of medication. The treatment of asthma requires not only treatment for relief of spasm, with drugs like salbutamol, but also drugs like steroids to prevent spasm from occurring by decreasing the allergy in the airways. However the long term use of oral steroids is marked by high risks of side effects like decreased

Immunity, diabetes, hypertension and bone disease, and is therefore inappropriate. The beneficial effects of steroids in prevention of attacks of asthma can be gained from taking steroids through inhalation route through inhalers have made their long term use a very safe option, and have revolutionized the treatment of asthma. Even salbutamol offers the advantage of rapid onset of action, lesser side effects and flexibility of dosing.

The Patient should also Receive Appropriate Information.

The concept of rational use of medicines also implies that the patients should receive the appropriate information about their disease and the medicines prescribed and are appropriately evaluated for the anticipated effects and side effects. For example a patient with diabetes who is prescribed an oral pill for lowering blood sugar, needs to be explained how to take them, what not to do while taking them (missing meals, going on a fast), the possible side effects in the form of development of low blood sugar (hypoglycemia), how to recognize the symptoms of low blood sugar, and how to treat the problem of low blood sugar. If the patient does not have this basic information, he may pay for it with his life. There are numerous instances when patients have developed low blood sugar, have not responded by taking sugar in some form because of lack of information, and have ultimately died into irreversible coma.

In the current situation of medical practice in India, the patient’s Right to Information is given short shrift, and any explanation on the drugs mentioned in the prescription is often perfunctory. This lack of information given by the doctors is compounded by the lack of information provided by the companies.

Rational Across Systems.

Rationality across systems is a poorly studied issue. Doctors across systems, and their various protagonists, tend to taken positions: if you are qualified in one system you cannot practice other system, unless you are qualified for it also. Some Allopaths, that is practitioners of Modern Western medicine, feel that there is no rationality, and therefore science, in other non-allopathic systems: a position hotly contested and one that soon gets us into issues of privileging one knowledge system over the other. But certainly we can ask for rationality within a particular medical system.

In this book, we are concerned with rationality within the allopathic (modern, Western Medicine) system only. A decision of the Supreme Court (Poonam Verma Vs. Drugs. Ashwin Patel in Cp No.8856 of 1994) prohibits cross practice: that is no medical practitioner will use medicines that do not belong to the system in which he is not educated and registered. See box below: In Violation of clear SC Ruling “Quacks” Continue to Conduct Clinical Trials.)

In Violation of clear SC Ruling “Quacks” Continue to Conduct Clinical Trials.

No practitioner of modern medicines is taught either during the course at the medical college or hospital training about the contents and properties of Pippalyadi Yoga. Yet believe it or not, it is being tested on humans, that too young females, to test if this product has any anti-fertility role.

In Poonam Verma Vs. Drugs. Ashwin Patel in Cp No.8856 of 1994), the  Supreme Court had outlawed “cross-border” practice and ruled  that n medical practitioner will use medicines that belong to the system in which he or she is educated and registered. In other words, allopaths are not permitted to use modern medicines.

The apex court had pronounced that a person holding, say MBBS, was a doctor in allopath but a “quack” in other systems  just like any lay person and will be “deemed” to be negligent per se without any further proof or argument” if found to be administering medicines belonging to other streams.

Pippalyadi oga has been developed by the Central Council for Research in Ayurveda and Sidddha and claims to contain Pippali, Vidanga a nd Tanakana. These substances are strange words for medical practitioners because they do not find any mention in the standard textbooks of pharmacology.

Strangely, the unauthorized and illegal  clinical trials are taking place at  the All India Institute of Medical Sciences (AIIMS), New Delhi; Post Graduate Institute (PGI), Chandigarh; JIPMER, Podicherry and King Edward Memorial Hospital, Mumbai, all managed by the government. Thus state-run institutions are violating Supreme Court Orders.

Because of their prescription powers, allopathic doctors are bombarded with promotional material Ayurvedic products even though it is unethical and illegal. Since doctors demand evidence of safety and efficacy, some manufacturers of Ayurvedic medicines go to the extent of sponsoring clinical trials of their products in medical colleges where unwittingly investigators are roped in for illegal trials.

In the past year alone, just two companies have conducted over a dozen clinical trials of Ayurvedic products at medical colleges in violation of Supreme Court ruling. Some examples:-

·        Safety and efficacy of branded Septilin by Drugs.Bharat J. Parmar at Department of Paedaitrics, B.J. Medical College, Ahmedabad.

·        Safety and efficacy of branded Opthacare by Drugs. Ulka Srivastava, Professor of Opthalmology, M.G.M. Medical College, Indore.

·        Safety and efficacy of branded Himocospaz by Drugs. Shakuntala Prabhu, Associate Professor of Bai Jerbai Wadia Hospital for Children, Mumbai.

·        Effct of branded Calcurosin in the management of urolithiasis by Dr. Lokesh Upadhyay at Institute of Medical Sciences, Varanasi.

·        Safety and efficacy of branded Diabecon in diabetes by Drugs. K.R. Kohli at R.A. Podar Medical College, Mumbai.

Unlike allopathic molecules, all these trials are conducted on formulations with trade names thus directly helping the manufacturers to increase their sales. Once the results of such trials are available, they are misused to induce practitioners to modern medicines to prescribe, an illegal act. Despite claims to the contrary, Ayurvedic products are not always safe. Many contain minerals and metals such as lead, mercury, arsenic etc. and have side effects. They can interact with ingredients of modern medicines about which allopaths are blissfully ignorant. The Medical Council of India should discharge its statutory duty and take urgent steps to ensure that the Supreme Court ruling is obeyed in letter and spirit.

(MMS India, Editorial, May 2005)

Guidelines for Rational Use of Drugs.

·        Prescribing a drug only when genuinely indicated.

·        Choosing drugs which are effective.

·        Using single-ingredient drugs.

·        Using drugs indicated for specific conditions

·        Choosing drugs which are relatively safe.

·        Choosing cheaper alternatives.

Some of the Steps needed to rationalize the use of drugs in the Market are:

·    Elimination of new drugs, which are expensive and not necessary because other drugs with proven efficacy already exist in the market.

·    Elimination of useless, hazardous and harmful drugs which have irrational combinations.

·    Use of essential drugs list.

·    Marketing of drugs by their generic names.

Causes of Irrationality

Irrationality in prescription of medicines is of two broad types: Using irrational drugs prevalent in the market, and irrational use of rational, essential drugs available.

Some of the common irrational prescription and treatment practices include:-

·        Prescribing antibiotics for ailments like diarrhoea or viral infection where they are useless, thus causing antibiotic resistance by the body when needed for dangerous diseases.

·        Prescribing combination products where one medicine is sufficient.

·        Prescribing unnecessary expensive vitamins or tonics, virtually regardless of the condition being treated.

·        Prescribing expensive new drugs in preference to established, less expensive ones.

·        Ordering of unnecessary investigations.

Who is responsible for allowing irrational drugs and irrational prescriptions? Government firstly, and then the drug companies, and then the medical profession and their professional associations for not being disciplined enough.

The reasons for irrational Prescribing.

1.      The belief of a pill for every ill.

2.      The more the merrier, combinations work better, and the belief in shotgun therapy.

3.      I have to cover all possibilities.

4.      The latest is the best (latest antimalarials, antibiotics, analgesics etc)

5.      Costlier is better, especially with poor quality drugs in the market.

6.      My professor said society…..

7.      The MR (medical representative) said society…..

8.      The patients demand it (or I will lose my practice)

9.      In my experience….

10.  The more I write the more I earn…

Some frequently Abused Drugs in India, Thanks to their Large-scale Prescription.

1. Vitamins   2. Digestives   3. Cough expectorant   4. Antibiotics   5. Injections

of all kinds    6. Analgesics

— Observations of a practicing physician doing rational practice.

Kolkata Declaration on Pharmaceutical Policy and Access to Essential Medicines

KOLKATA DECLARATION

Adopted in the

National Seminar on Pharmaceutical Policy and Access to Essential Medicines

Kolkata on 16-17 April, 2005

The National Seminar on Pharmaceutical Policy and Access to Essential Medicines organised by Jan Swasthya Abhiyan, Federation of Medical and Sales Representatives’ Associations of India, National Campaign Committee for Drug Policy and All India Drug Action Network and supported by the World Health Organisation, India country office discussed different aspects of the country’s pharmaceutical policy. The seminar was attended by one hundred and twenty eight activists, academics and experts from all parts of the country that deliberated on different issues related to the pharmaceutical sector in India.

The Seminar noted that the country’s record in controlling diseases that affect large sections of the people has been far less than satisfactory.  The country faces new challenges in the form of increased incidence of “lifestyle” diseases and infections such as HIV-AIDS. This ominous situation admitted in the National Health Policy-2002 needs to be addressed seriously. Disease pattern and common ailments highlighted in NFHS-2 survey should also be taken in consideration.

The seminar also noted the new situation created by the policy of globalisation, privatisation, liberalization and the new product patent regime which together have threatened the national self reliance as well as availability and affordability of essential medicines. The seminar felt concerned about the worsening situation on the drug price front with its disastrous impact on the poor.  With this back ground the seminar expressed the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from health movements.

Given the above the Seminar resolves the following suggestions be considered while making the National Pharmaceutical Policy.

National Essential Medicines List

1. The Govt., based on epidemiological data, should update the National Essential Medicines List (NEML) and also prepare a Graded Essential Medicines List that is appropriate for each level of the health care system. The National List needs to be adopted by different states and adapted by them based on local conditions and disease profile.

2. The Govt. should monitor and ensure the availability of Medicines listed in the EML. Production of these medicines from the basic stages should be ensured through production control mechanisms.

3. It should be made mandatory that the procurement and use of medicines in Govt. hospitals and public sector undertakings be done based on the NEML .Such procurement should be through transparent procedures. Regular training and incentives to promote use of medicines in the NEML should be provided.

Irrational and Hazardous Drugs

  1. Given the proliferation of irrational and hazardous medicines in the market, a special committee of the DTBA should be set-up to weed out all such medicines including irrational Fixed Dose Combinations (FDC) within a stipulated period. Hence forth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should be banned and should not be allowed to be marketed. All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy and need.
  2. Injectable contraceptives, transdermal implants and anti fertility vaccines should not be used in the National Family Planning Programme.
  3. Adverse Drug Reaction (ADR) Monitoring Centres should be set up in all states of the country and be provided with sufficient resources.
  4. When a substantial number of ADRs are reported either in India or abroad for a drug, the same should be referred to the DTAB for withdrawal.

Generic Drug Use

In order to encourage use of medicines in generic names, all medicines sold under generic names should be exempt of duties and taxes. All packages of medicines should carry the generic name more prominently than the brand name.

Medical Education

The curriculum for medical education should include the concepts of essential drugs and rational prescription practices.

Indian Patents Act

  1. The Govt. should keep advocating for keeping TRIPS out of WTO provisions and advocate for reopening the issue of exempting the developing countries from Product Patent.
  2. The Govt. should ensure that all the flexibilities in the Act are used to promote health and development of the indigenous drug industry.
  3. The Govt. should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
  4. The Govt. should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
  5. Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export market exists and is not being addressed.

Drug Production and Availability

  1. To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced.
  2. Production Control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from NEML that are Essential.
  3. The new policy of allowing 100% equity participation of MNCs in the pharmaceutical sector needs to be changed and majority equity participation by the multinational companies should only be permitted if new technology is brought in by them for manufacturing and research.
  4. Restrictions in the form of tariffs and other non-tariff measures should be imposed on the import of bulk drugs or formulation for which adequate production capacities exist in the country.
  5. Prevailing systems of loan license or third party license should be abolished. Mention of the name and address of the manufacturer should be clearly indicated on the label of each medicine, and the license holder should be held responsible for all complaints, compensation and replacement of medicines.

Drug Pricing

  1. drugs should be brought under price control given the fact drug expenditure in India is more than half the health care expense and also because more than  80% of health care expenditure is met by patients themselves.  Mechanisms that are transparent and easy to administer should be put in place to control prices and the system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
  2. Trade margin, those to including wholesalers and retailers should not go beyond 30%.
  3. National Medicines Pricing Authority should be established as a quasi judicial body which should be given sufficient legal power to punish manufacturer for violation of ceiling prices.
  4. For imported medicines, provision of cost data and manufacturers price certificate should be made mandatory.
  5. All cancer and HIV/AIDS medicines and orphan medicines should be exempt from all taxes and duties, including import duties.

Public Sector

The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. Public sector medicine companies such as IDPL and HAL should be revived and they should be provided with the support in the form of sectoral reservation, preferential treatment in the cases of Govt. purchases, etc. These companies would need to be provided a leading role in drug manufacture in the case of compulsory licenses issued in situations of national emergency and extreme urgency. New public sector companies should be promoted for producing those essential medicines that are not being produced by private companies at an affordable cost.

Research and Development

  1. A major national effort should be made to increase original drug research based on the strength of our national research institutes, laboratories and the Universities and also on the biodiversity and the medicinal plant wealth of our country. The research institutions should be provided with adequate funds for drug research .Regional drug research centres may be established in states where infrastructural facilities are already available. Universities should be encouraged to offer courses so as to produce adequate and high quality human resource pool for modern drug research related activities.  The Public Sector should be promoted to play the leading role in R&D activities.
  2. Public funded Research Laboratories should co-ordinate their activities. The research activities of publicly funded research organisations should not duplicate empirical drug discovery projects in the pharma R&D model, but should concentrate on generating the knowledge base for the identification and exploitation of new intervention points for medicines.
  3. All medicines developed in the country should be exempt from taxes and duties for 10 years.
  4. A comprehensive legislation on the ethical conduct of clinical trials should be enacted in line with the Helsinki Declaration and other international covenants, treaties and declarations so as to provide for strict guidelines for obtaining informed consent, for protection of the health of subjects of such trials.
  5. Outsourcing of clinical trials for MNCs should be closely monitored by a specially constituted Standing Ethics Committee set up in each state.
  6. All information about protocols and the results of the clinical trials approved by the DGCI should be in the public domain.
  7. Phase IV of the clinical trials should be mandatory and should not be replaced by the PMS studies by he pharmaceutical companies.

Quality Control and Drug Information

  1. The manufacturer should be fully responsible for the quality of a medicine. A separate Food and Drug Court should be made responsible for redressal of complaints and for trial of those responsible for manufacture and sale of spurious and sub-standard drugs.
  2. The Drugs and Cosmetics Act should be suitably amended to provide for exemplary punishment to those found guilty.
  3. The drugs control organisation both at state and central levels should be adequately strengthened in terms of infrastructural facilities and human resources.
  4. Each state should have at least one well equipped drug testing laboratory under the control of the state drug controller.
  5. The state and central drugs controllers should have their own websites. Among other information these websites should publish updated information on banned and withdrawn drugs including their brand names as well the current laws in operation.
  6. A consensus should be developed after discussion with manufacturers of all sectors for developing minimum benchmark of good manufacturing practice which then can be embodied in the Schedule ‘M’ of the Drugs & Cosmetics Act.
  7. Consumers should be allowed to get tested medicines of doubtful quality at any Govt. approved test laboratory.
  8. New colleges of pharmacy should be opened to eventually ensure that all retail pharmaceutical outlets have the services of a trained pharmacist.
  9. The outdated Magic Remedies Act should be replaced by a new Act.
  10. To disseminate unbiased information of medicines, Govt. should develop an independent process for information. The National Formulary should be updated and published regularly. Standard treatment protocols and guidelines for common ailments and for every tier of the health system should be prepared and disseminated. Doctors, pharmacists and staff nurses should be trained in treatment protocols and guideline.  All hospitals and medical centres should be encouraged to prepare and use their own formularies.

Drug Promotion

  1. A National Ethics Committee on Promotion of Medicines (NECPM) in which there is adequate representative of civil society organisations should be formed to monitor all promotional efforts
  2. A code of ethics for marketing of medicines should be adopted by NECPM and made obligatory for all the manufacturers.
  3. All promotional materials for health professionals should be screened and approved by NECPM and all advertisements in the regional press be scrutinized and approved by a state level Ethical Promotion Committee.
  4. Gifts except minor items, inducements, sponsoring of meetings and entertainment of the members of the medical profession and those who are related to drug prescription, purchase etc by drug companies should be banned so that these do not influence prescribing practices.
  5. Drug companies should contribute funds to the drug control authority for the conduct of Continuing Medical Education programme for doctors
  6. A cap on drug promotional expenditure drug companies should be fixed and enforced.