 "Pharmaceuticals, drugs, pharma industry, medical, health, lab")
The government’s ban on 14 fixed dose combination (FDC) drugs in "larger public interest" will affect around Rs 824 crore of the domestic pharmaceuticals market, said a research firm citing data.
Abbott, Mankind and Dr Reddy’s Laboratories are companies which make products that come under the banned FDCs, according to Pharmarack AWACS.
A FDC combines two or more active ingredients into a single drug formulation in a fixed dosage ratio. The government announced the ban last week upon the recommendation of an expert committee which said the FDCs had no "therapeutic justification". “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDC under section 26A of the Drugs and Cosmetics Act, 1940,” said a notification by the Health Ministry.
Pharmarack AWACS' analysis found that most FDCs are for respiratory therapy and the banned products contribute 7 per cent (Rs 786 crore) of the overall respiratory therapy market (Rs 1,1174 crore).
Most FDCs have shown an encouraging five-year growth in CAGR, said Sheetal Sapale, president of marketing at AIOCD-AWACS.
Almost 72 pharmaceutical companies have brands that fall under banned FDCs. “Around seven companies have exposure of Rs 2 crore and above. However, the contribution of this portfolio to their overall turnover is miniscule – in the range of 2-3 percent. Companies like Franco, which have legacy respiratory brands, may have more impact,” said Sapale.
One key banned FDC is a commonly used medication combination—Nimesulide and Paracetamol-- used to relieve pain and fever. Certain antibiotic FDCs have also been banned, including a combination of Amoxicillin and Bromhexine used to treat respiratory tract infections. Codeine-based formulations for treating runny nose, sneezing, cough and common cold symptoms are banned, too.
V Krishnakumar, executive director and chief operating officer of Eris Lifesciences, said new FDC launches have come down. “Earlier one could take a state licensing authority approval and launch a combination. Now one needs a Drugs Controller General of India (DCGI) approval. For any novel combination, Pharma companies need to submit clinical trial data,” he said.
The ban is the latest in a crackdown on FDCs. The Health Ministry banned 349 FDCs in March 2016 after the Chandrakant Kokate committee found the drug combinations were irrational and posed health risks. The Supreme Court referred the matter to the Drug Technical Advisory Board (DTAB) for a review after drug companies challenged the ban. The DTAB, in a meeting held in July 2018, reinforced the ban on 343 of the 349 drugs. The market value of the 349 drugs was estimated to be around Rs 2,000 crore at that time.
The Centre last year proposed to ban 19 codeine-based FDCs. Codeine is an antitussive (medication that suppresses cough) and it is used for treating dry cough. Such kinds of coughs are basically attributed to allergic manifestations or to patients working in dusty environments. Codeine-based formulations make for a Rs 1000-crore market roughly.
The Indian Drug Manufacturers Association (IDMA) made a representation to the government that codeine-based cough syrups are clinically safe and must not be banned because a few people misuse them.
