A 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, is set to begin its hearing in coming weeks as it seeks views from various stakeholders, including the NGOs working in healthcare sector.
The sub-committee of DTAB, headed by Nilima Kshirsagar, the Chair in Clinical Pharmacology of Indian Council of Medical Research (ICMR) – Mumbai, will do a fresh review of the banned FDCs to verify their safety, efficacy and therapeutic justification before recommending an action.
The DTAB sub-committee has been given six months to complete the hearing process.
The DTAB, which is part of the Directorate General of Health Services, Office of Drugs Controller General (India) – FDC Division has called the All India Drugs Action Network (AIDAN), a group of healthcare-focused NGOs, to give its views.
AIDAN was given time till April 7 to submit its views.
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 ban shaved around Rs 10,000 crore in sales from the Indian pharmaceutical market which is worth over one trillion rupees impacting most Indian drug makers including the multinational companies.
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.
“AIDAN looks forward to placing its considered views before the Kshirsagar subcommittee appointed by the DTAB in accordance with the Supreme Court Order of December 15, 2017,” said S Srinivasan, Co-Convenor of AIDAN.
AIDAN said it is yet to receive formal intimation of the notice from the government to AIDAN or its legal counsel.
“The matter of ban of the 344 FDCs as also many other FDCs is important from the point of view of public health and safety for consumers as many of these FDCs have been found wanting in either efficacy, safety and/or therapeutic justification. These FDCs do not find mention in any standard pharmacology textbook,” AIDAN added.
The Supreme Court upheld the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act by the government. 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.moneycontrol