AIDAN welcomes the DTAB sub-committee’s report and its recommendations on the 349 FDCs which in summary are to ban 343 of the FDCs and to restrict/regulate the remaining 6 FDCs.
It reinforces our constant demand for approval, and use, of only rational medicines in India. Rationality needs to be demonstrated by safety, efficacy and therapeutic justification. None of the FDCs meet the criteria of a rational and safe FDC. The people of India have been made the consumers of unsafe medicines for too long and this is one step towards rectifying the grave situation of a pharma market brimming with innumerable irrational FDCs.
When the ban on FDCs was notified, pharma companies in court cases questioned the locus standi and powers of the Central Government to ban drugs in India. That issue has been settled decisively with the recommendations of the sub-committee led by Dr. Kshirsagar.
In the legal battle in which AIDAN was a petitioner (Civil Appeal No. 22972/2017 and related cases), the Supreme Court ruled that as long as the Government is satisfied that a drug has unacceptable safety, efficacy and/or therapeutic justification, it may ban or regulate or restrict it in public interest. The Court further clarified that for such satisfaction to be obtained, consultation with the DTAB is not mandatory. Therefore, another red herring was laid to rest. The case had also, hopefully, sent a message that new drugs including FDCs cannot be licensed by the States for manufacturing, without prior Central Government approval; as well as a message to pharma companies that the system cannot be gamed through bypassing regulatory requirements.
The important remaining issue of the 344+5 FDCs has finally been resolved, in compliance with the December 15, 2017 Supreme Court verdict, pending of course formal notification by the Ministry of Health and Family Welfare. With this development, India’s regulatory system and its judicial system stand redeemed.
We note however, that the FDCs under scrutiny account for approximately Rs. 2,500 crore in sales and represent only the tip of the iceberg. In our estimation, the market of unsafe, problematic FDCs in India is at least one fourth of the total pharma market valued at Rs. 1.3 trillion.
The task that remains is combating the continued prevalence of a very large number of FDCs of doubtful scientific validity which have somehow slipped through the net and been approved wrongly by the Central Government. Review of all such FDCs in the market is required in the interest of patient safety. Such a review had also been recommended by the Kokate Committee. Only then can India’s pharma regulatory system hope to garner respect across the world.
Finally, we are appalled at the pharma industry’s disinformation and claims that the recommendations of the sub-committee will deal a huge blow to it. We ask how an important action in favour of safe medicines can be construed as a “blow” and object to such misleading propaganda.