As many as 343 fixed-dose combination (FDC) medicines are likely to get banned shortly, a move recommended by the Drugs Technical Advisory Board (DTAB).
These include popular brands like Saridon, D'Cold Total and Phensedyl.
However, industry insiders say the impact on the market is expected to be marginal.
This list comes after a list of 349 was pruned by the DTAB on the SC's instructions.
The battle between the government and manufacturers
The proposal comes after a long-drawn battle between the government, which decided to ban 349 "unsafe" and "irrational" drugs in 2016, and manufacturers.
Top companies like Pfizer, P&G, Wockhardt, Cipla and Dr Reddy's moved the Delhi HC against the decision, which ruled in their favor.
The government then approached the SC, which asked a sub-committee of the DTAB to submit its recommendations to the government.
What are FDCs?
Following consultations with 400 companies and other stakeholders, the sub-committee has submitted a list of 343 FDCs.
FDCs are cocktail drugs comprising two or more ingredients mixed in a fixed dose. These are usually recommended in cases of fever, headache and infection.
The DTAB list includes combinations like paracetamol + propyphenazone + caffeine, paracetamol + phenylephrine + caffeine, and chlorpheniramine maleate + codeine syrup.
Committee also flags issues with the companies' actions
The panel noted that "most" companies fighting the proposed ban hadn't generated safety and efficacy data of their products. The literature they had submitted to defend the FDCs was "not relevant" and took into account only a few "biased" studies, it added.
Manufacturers have already implemented different corrective measures
If the ban is approved, the manufacture, sale and distribution of these drugs will be prohibited, affecting MNCs like Abbott and domestic companies like Piramal.
The industry expects a limited impact: since 2016, many manufacturers have changed composition of their products, or have discontinued production of flagged FDCs, or launched variants.
The sales value of these medicines has fallen from Rs. 3,000cr in 2016 to Rs. 2,183cr now.
Final decision expected shortly, draft list may undergo changes
A health ministry official told ET the final decision will be out next week. "The ministry will duly ban 343 FDCs," they said. Another senior official said the matter is still "under examination," and the draft list may undergo minor changes before the final notification.