Following 66 pharma companies having launched combination drugs without approval since 2013, the National Pharmaceutical Pricing Authority (NPPA) has issued notices to pharmaceutical companies in violation of the Drug Price Control Order (DPCO) asking them to submit batch-wise production and sales details, and maximum retail price of these drugs from the date of launch, along with reasons for non-compliance by June 15, 2017.

In total, 201 combination drugs have been launched without NPPA approval since 2013 by the pharma companies, including Alkem Laboratories, Cadila Healthcare, Eris Lifesciences, Abbott Healthcare, Glenmark Pharmaceuticals, Lupin, Sanofi India, Sun Pharmaceutical Industries and Wockhardt.

“Some pharmaceutical companies have launched formulations by altering a scheduled formulation, with strength other than as specified in DPCO 2013 and/or in combination with other non-scheduled medicines without even applying for price approval from NPPA as required,” the regulator said in the notice posted on its website.

NPPA notice also stated that it is unclear whether these drugs have approval from the Central Drugs Standard Control Organisation (CDSCO) or whether they are rational or irrational drugs, considering that many of them are fixed dose combination drugs.

As per DPCO provisions, companies are liable to deposit overcharged amount for these drugs with interest from the date of launch, along with penalty.

According to NPPA’s guidelines on overpricing of drugs, if a company does not respond to a show-cause notice regarding overcharging of a drug, the regulator, after issuing one reminder and giving 15 days to the company, shall fix the price of the medicine and calculate the overcharged amount based on the difference between its price and the maximum retail price. The company will also have to pay a penalty, not less than 100 per cent of the principal amount.