Delhi High Court Quashes Government Ban On Fixed Dose Combination Drugs
Pharma companies can sell fixed dosage combination drugs now.
Indian pharmaceutical companies got some relief from the Delhi High Court on Thursday, after it quashed a government order banning 344 Fixed Dose Combination (FDC) drugs.
The court was hearing a plea filed by pharmaceutical companies challenging the March 10, 2016 order which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and anti-diabetes combinations.
The pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and not in keeping with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They went on to argue that the decision was taken without considering clinical data and based on an ‘absurd’ claim that there are safer alternatives available in the market now, according to a report filed by the Press Trust of India.
FDCs are a combination of two or more drugs in fixed ratio doses, traditionally made to improve therapeutic effect/efficacy and patient convenience.
Market research organisation AIOCD AWACS had estimated the overall annual sales impact of the ban on the pharmaceutical market to be around Rs 3,000-3,500 crore or 3.5 percent of the Indian clinical drug market, after the ban came into effect. Pharmaceutical companies had been severely impacted in the first quarter of the current financial year, after the ban came into effect, with most companies registering a sharp dip in their quarterly growth figures. The additions made to the list price controlled drugs falling under National List of Essential Medicines 2015 (NLEM) had only added to their woes. However, domestic sales in India had recovered in Q2FY17.
Companies Who Stand To Benefit The Most
A March 2016 dated Nomura report had estimated Pfizer, Ipca Laboratories Ltd., Wockhardt Ltd., Alkem Laboratories Ltd. and Glenmark Pharmaceuticals Ltd. among others were to take the biggest hit in India.
Pharma Stocks Headed Higher
Cipla, Lupin, Dr Reddy’s, Cadila Healthcare, Wockhardt, Pfizer, Indoco Remedies were trading 1-2% higher on this announcement.