The DTAB Sub-Committee will do a fresh review of the banned FDCs on case-by-case basis to verify their safety before recommending an action to the govt
The All India Drug Action Network (AIDAN) - a group of healthcare-focused NGOs - has expressed dismay over government appointing representatives of professional bodies such as Indian Pharmaceutical Association (IPA) and Indian Medical Association (IMA) as members of Sub-Committee of Drugs Technical Advisory Board (DTAB), which was directed to take a re-look at the banned 344 fixed dose combination (FDC) drugs by Supreme Court in December last year.
The DTAB Sub-Committee will do a fresh review of the banned FDCs on case-by-case basis to verify their safety, efficacy and therapeutic justification before recommending an action to the government.
According to the minutes of the 78th meeting of DTAB, held on February 12, which Moneycontrol verified, the Sub Committee headed by Nilima Kshirsagar, the Chair in Clinical Pharmacology of Indian Council of Medical Research (ICMR) - Mumbai, had six other members including VSV Vadlamudi, President of Indian Pharmaceutical Association, OS Sadhwani, Joint Commissioner, FDA, Maharashtra, (Member), Sanjeev Kumar Gupta of CDSCO, two representatives from Indian Medical Association, New Delhi, and Mumbai and a clinical pharmacologist. The last three members are yet to be named. DTAB said the committee may co-opt subject experts as and when required.
The Sub Committee was given three months time to submit the report. Moneycontrol this week wrote that the Sub Committee will be beginning its hearing on the banned FDCs. The committee invited AIDAN to give its views by April 7.
However it's the composition of DTAB sub-committee that included members of professional bodies IPA and IMA that became bone of contention.
"The appointment of these three members, on the basis of their membership in professional associations, do not meet the criteria of expertise and objectivity required for deciding on the findings of another expert body - the Kokate Committee," said AIDAN in a letter signed by its member Dr Mira Shiva, who leads People's Health Movement.
AIDAN also accused commercial and conflict of interest of the members representing professional bodies with industry and asked DTAB to remove them and reconstitute the Sub-Committee. It further asked the members of the re-constituted Sub-Committee to declare their conflict of interests, if any.
"Many members of the Indian Pharmaceutical Association are affiliated with the pharma industry. There are thus clear, organic conflicts of interest. Further, the IMA is a body particularly known for its conflict of interest with respective commercial endorsements and vis-a-vis the pharma industry. The Sub-Committee report headed by Dr Kshirsagar will therefore lack credibility in a matter of grave public health interest if it includes such members," AIDAN said.
"In the light of these observations, we request: that the Sub-Committee be re-constituted removing these members, namely the representative of the IPA and IMA, that have commercial interests and conflict of interest. That without prejudice to the above, the members of the re-constituted committee should also declare their conflict of interest, if any, in respect of serving on the committee and that these declaration be made public," AIDAN added.
AIDAN also sought extension of deadline by one more month from April 7 to submit its views.
"Finally, we find the deadline given to us for the submissions on more than thousand formulations (related to the 344 impugned FDCs) is very short - less than four weeks - and therefore it is impossible to comply meaningfully with request for submissions. We request that the deadline be extended by another month," AIDAN said.
FDC refers to a cocktail or combination of two or more drugs into a single pill. India is flooded with FDCs, at least one in two medications sold in India will be some kind of an FDC.
FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, hepatitis-C, malaria and tuberculosis, where giving multiple antimicrobial agents is the norm. FDCs are also useful for chronic conditions especially, when multiple disorders co-exist.
Pharma companies have aggressively pushed FDCs on grounds of improved efficacy, better compliance, reduced cost and simpler logistics of distribution.
But the real reason analysts say is to bypass drug price control as FDCs are treated as new drugs.
Much of combination drugs sold in India are untested drug cocktails with no clinical justification other than commercial intent.
In an attempt to weed out irrational drug combinations from the Indian market - in 2016 the government banned over 344 FDCs for a wide range of medical conditions saying that the combinations had "no therapeutic justification."
The government based its decision on Kokate Committee which examined 6,214 FDCs and in its final report which was submitted to the Central Government on February 10, 2016 recommended the outright banning of 1083 FDCs on the grounds that they were irrational combinations.
While the industry says the ban could have shaved off Rs 10,000 crore per year in sales from the Indian pharmaceutical market which is worth over one trillion rupees, market research firm AIOCD puts the loss figure at modest Rs 4000 crore.
The ban was challenged by pharmaceutical companies on grounds that the government action was unilateral and didn't give them sufficient hearing before it went ahead with the prohibition notification.The apex court clarified that for the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the government in order to be convinced of reasons for banning a medicine. The court remarked that the government could be justified in declaring a ban if it finds that the drug has been banned in other countries.