NEW DELHI: The health ministry may soon ban over 300 fixed-dose combination (FDC) medicines, accepting recommendations of a sub-committee of India’s apex drug advisory body. The move, which is expected to impact top MNCs such as Abbott as well as domestic players such as Piramal, Macleods, Cipla and Lupin among others, could be challenged in the courts once again.
If the initial draft ban notification that EThas viewed are implemented, the ban would cover popular cough syrups, pain killers and flu medicines like Phensedyl, Saridon and D’Cold Total. The draft lists out 343 FDCs that the ministry plans to ban manufacture, sale and distribution of and has been prepared based on recommendations of the Drug Technical Advisory Board (DTAB).
The Supreme Court had last year asked the DTAB to recommend to the health ministry which FDCs should be regulated or restricted or banned outright along with reasons for doing so. This followed an extended legal battle between the government and drug companies over the FDC ban issue.
The final notification is expected in the coming week, said officials in the know. “The health ministry will duly ban 343 FDCs,” confirmed one official.
However another senior health ministry official cautioned that the draft will get amended before the final version is presented. “The matter is still under examination,” he said.
FDCs are cocktail drugs that consist of two or more therapeutic ingredients packed in a fixed dose. The FDCs in this draft include combinations like paracetamol + phenylephrine + caffeine, chlorpheniramine maleate + codeine syrup and paracetamol + propyphenazone + caffeine. The FDCs that could be banned account for about two per cent of India’s over Rs 1 lakh crore drug market, according to market research firm AIOCD PharmaTrac.
Health ministry likely to ban over 300 combo drugs
The annual sales value of these medicines has shrunk from nearly Rs 3,000 crore in 2016 to Rs 2,183 crore now.
Analysts See Limited Impact of Ban
Makers of these drugs have either changed the compositions of their FDCs or discontinued production of some brands that fell into the ‘banned’ category to focus on other products in their portfolio.
Some analysts believe that the impact of the ban will be limited. “Apart from a couple of big brands like Phensedyl, most of the other brands are very small and the ban will have marginal impact.
Companies knew that this was coming and so they have launched variants that would be compliant with regulations and are hoping that they will be able to switch a significant number of their patients to these variants in case the ban is reinstated,” said Abhishek Sharma, Pharma Analyst at IIFL.
One official of a pharmaceutical company added that the industry would wait for the final decision before taking a call on the next steps.
In certain cases where companies may have a line of products under the same brand and the ban would impact only one, they would focus on building the other products in that line, said the person, also requesting anonymity.
The proposed ban follows a longdrawn court battle between the government and hundreds of pharmaceutical companies since 2016 over the health ministry’s decision to ban 349 such drug combinations for allegedly being “unsafe” and “irrational”.
The banned combinations belonged to several therapeutic areas like cough and cold syrups, respiratory formulations and even topical dermatological medicines. Pfizer, Glenmark, Procter & Gamble, Abbott, Sanofi, Wockhardt, Cipla, Lupin and Dr Reddy’s were among the companies that opposed the ban in 2016. The Delhi High Court, which had heard a chunk of the petitions against the move, ruled in favour of the industry and had said the government had not gone through the statutory bodies that are to take a call on such matters. The government appealed the matter in the Supreme Court, which in turn asked the sub-committee of the DTAB to submit its recommendations to the government.
Following consultations with over 400 pharmaceutical companies and various other industry bodies and patient groups, the sub-committee recommended that 343 of the 349 FDCs should be banned, said a senior government official requesting anonymity.
According to documents viewed by ET, the sub-committee had found that “most” of the companies appealing the ban had not generated safety and efficacy data of their own for their FDCs.
The published literature they provided to justify the FDCs was “not relevant” and relied on a few “biased” studies, the sub-committee is learned to have stated.