Government prohibits 328 fixed dose combinations

The ban is effective immediately and may shave off over Rs 1,500 crore from India’s Rs 1.18 lakh crore pharmaceutical industry

Prabha Raghavan&DIVYA RAJAGOPAL
Advt.

The health ministry pruned a list of banned combination medicines and added restrictions to the dosages or uses for six more types of such drugs, saying their ingredients had no therapeutic value and were risky for consumption.

The ban on 328 such drugs — compared with 344 earlier — is effective immediately and may shave off over Rs 1,500 crore from India’s Rs 1.18 lakh crore pharmaceutical industry. Brands going off pharmacy shelves include Saridon, Panderm Plus and Taxim AZ, according to market research firm AIOCD Awacs PharmaTrac.

Such drugs, known as fixed dose combinations (FDCs), are cocktails of two or more therapeutic ingredients. The ministry’s decision was taken after its Drugs Technical Advisory Board (DTAB) said the ingredients of these FDCs have no therapeutic justification and they may be risky to consume.

“The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs… in the larger public interest,” the ministry said in a release on Wednesday.

The ministry had considered the recommendations of DTAB as well as an expert committee it had set up a few years ago to look into the safety and rationality of these medicines.
Government prohibits 328 fixed dose combinations
In view of the recommendations, “any kind of regulation or restriction to allow for any use in patients is not justifiable,” the ministry stated in one of the ban notifications, a copy of which ET has viewed.

The manufacture, sale and distribution of six FDCs will be subject to certain conditions based on their therapeutic justification.

They include two combinations to treat diabetes and the restrictions would apply to diabetes brands Microlabs’ Tripride, Abbott’s Tribet and Lupin’s Gluconorm-PG, according to PharmaTrac.

ET’s queries to Piramal, Alkem, Microlabs, Abbott and Lupin remained unanswered by press time on Wednesday. Macleods Pharmaceuticals, which makes Panderm Plus, said it would not be able to respond until the notifications are in the public domain.

However, an official from Macleods who did not wish to be identified said the company has already started working on a new combination for Panderm Plus approved by India’s apex drug regulator.

The latest ban no longer includes top cough syrups and cold medicines Phensedyl, Grilinctus and D’Cold Total, which belong to combinations manufactured since 1988, according to senior ministry officials. It is in compliance with a Supreme Court order of December 2017 asking for the DTAB to review the matter.

The ministry first banned 349 FDCs in 2016 and 2017, claiming they were “unsafe” and “irrational” for human use, initially impacting over Rs 3,000 crore of the pharma industry and large companies including Pfizer and Abbott. Since then, pharma companies have cut down their drugs in the FDC category.

Data from PharmaTrac shows the FDC market grew 2.2%, while the non-FDC market grew 8.9% in August. The ban has hurt drug makers such as Mankind Pharma, which is stopping FDC products.

“We are slowly exiting FDC products because of this constant sword of ban hanging over our head. So that’s why our growth too has come down,” Ramesh Juneja, chairman of Mankind Pharma, told ET.

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