The pharma firm termed the retail price of Rs. 8.76 per tablet and Rs. 9.06 per tablet, respectively, excluding GST, as illegal and arbitrary. It also claimed that its formulations are “new drugs” approved by the Drugs Controller General of India (DCGI) and are exempt from the Drugs (Pricing and Control) Order, 2013.
Justice Subramonium Prasad sought response from the Ministry of Chemicals and Fertilisers and the National Pharmaceutical Pricing Authority (NPPA) on the Glenmark’s petition which also sought the quashing of notices, decisions and standing order issued taken by the authority against it for selling the formulations comprising of “Remo MV” ‘Remogliflozin Etabonate 100 mg + Vildagliptin 50mg + Metformin Hydrochloride IP 500 mg Tablets’ and ‘Remogliflozin Etabonate 100 mg + Vildagliptin 50mg + Metformin Hydrochloride IP 1000 mg Tablets’, without obtaining prior price approval under the 2013 Order.
Senior counsel Arvind Nigam and counsel Debmalya Banerjee and Rohan Sharma argued that these formulations being “new drugs” within the meaning of Rule 122E of the Drugs and Cosmetics Rules, 1945 (DCR), have been approved by the Drugs Controller General of India (DCGI) and were commercially launched under a valid patent granted under the Patents Act, 1970.
According the counsel, the NPPA has proceeded on the basis of an “arbitrary and erroneous interpretation” that the exemption under paragraph 32 of the DPCO 2013 cannot be “self-invoked” and instead required Glenmark to obtain an exemption from the former in respect of its formulations.
“No procedure has been prescribed for availing the exemption under paragraph 32 of the DPCO 2013 or under any other guidelines, directions or office memorandum by NPPA, the petition stated, adding that the government could not have proceeded to issue notices and fix prices, without any authority or jurisdiction and also in violation of principles of natural justice as the decisions have been taken without giving any hearing to the pharma firm.Similar notices issued to other homegrown pharma majors like Lupin, Abbott Healthcare, Sun Pharma Labs and others are also under challenge before the HC.
