Delhi High Court quashes government’s ban on over 300 medicines
The Delhi High Court on Thursday quashed the central government’s order to ban 344 fixed-dose combination medicines.
The decision has brought a major relief to over 300 pharmaceutical companies. The ban was notified by the government in March this year under which 344 fixed-dose combination (FDC) medicines, including well-known brands like Corex cough syrup, Vicks Action 500 extra, Saridon and D-Cold were banned.
The banned combinations, which affected 6000 medicines brands, belonged to several therapeutic areas like cough and cold syrups, respiratory formulations and even topical dermatological medicines.
The pharmaceutical companies had rushed to the Delhi High Court arguing that the move of the government was arbitrary and bad in law. Glenmark, Procter & Gamble, Abbott, Sanofi, Wockhardt, Cipla, Lupin and Dr Reddy’s were some of the companies among the hundreds of petitioners that opposed the ban.
The government had defended its move arguing that these drugs were unsafe, not efficacious and there was no therapeutic justification to consume them.
Companies had argued that their brands had been in the market for decades, with some even producing no objection certificates (NOCs) granted by the central drug regulator for their combinations.
A fixed dose combination (FDC) is a cocktail drug that contains two or more therapeutic ingredients packed in a single dose. According to government sources over 2000 FDCs exist in India. FDCs are desirable here for their effectiveness in treating many symptoms of illness at a lower cost than two or more separate medicines.
The government had said that there was a need to safeguard public from irrational FDCs, irrespective of the manufacturer. Some NGOs such as the All India Drug Action Network (AIDAN) had also supported the government’s move.