NPPA issues show cause notices to 67 pharma firms
New Delhi, May 2017:
The National Pharmaceutical Pricing Authority(NPPA) has issued show cause notices to 67 pharmaceutical companies for introducing 201 new brands without taking price approval.
The 67 companies include many major players: Abbott Healthcare, Alkem, Biocon, Cadila, Dr Reddy's Laboratories, GSK, Glenmark, Intas, Lupin, Mankind, Novartis India, Ranbaxy Laboratories, Sanofi India, Strides Shasun, Wockhardt and Zydus Cadila, among others.
Sun Pharmaceuticals, which owns Ranbaxy Laboratories, told The Indian Express: "This showcause (notice) has been posted this evening.
We will check every product listed in the notice to ascertain their status and respond to the regulator within the stipulated timeframe. Sun Pharma is committed to compliance on all regulatory matters." The NPPA has issued Ranbaxy with the show cause notices for nine specific brands.
Similarly, Glenmark Pharmaceuticals' three brands - Milixim AZ, Milixim Turbo and Vorth TM - were listed as being without approval. Glenmark said: "We have just learnt of the matter from the NPPA website. We will examine the matter and will respond…"
Most of 201 new brands are fixed dose combinations (FDCs). When two or more active drug ingredients are contained in a single dosage form, such as a capsule or tablet, it is known as an FDC. On Wednesday, the NPPA stated: "During the monitoring of compliance of various provisions of Drug Prices Control Order, 2013 (DPCO, 2013), it is seen that the provision related to the 'new drugs' have not been followed by some companies."
According to the NPPA, the 67 companies launched their new drug brands by altering a scheduled formulation "with strength/dosage 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 under Para 15 (2) of DPCO, 2013".
As per Para 2(u) of the DPCO, 2013, when a drug, which is listed in National List of Essential Medicines (NLEM) with specific dosages and strengths, is combined with any other drug, it is called a 'new drug'. Moreover, if a drug, which is listed in NLEM with specific dosages and strengths, is launched by "changing the strength or dosages or both", it is also called a 'new drug'.
The DPCO, 2013 has been issued by the Centre under the powers conferred by section 3 of the Essential Commodities Act, 1955. Any contravention of the provisions of DPCO, 2013, is punishable in accordance with the provisions of the Essential Commodities Act, 1955.
Therefore, as it is decided to take action against these 67 firms, the NPPA stated: "The concerned firms are required to furnish batch wise production and sales details along with the corresponding MRP (maximum retail price) duly certified by a chartered/cost accountant for the formulations indicated in the list, from the date of the launch of the production till date, along with the reasons for non-compliance of the provisions related to the 'new drug', to this office positively by June 15, 2017."
The NPPA has said that if replies are not received by June 15, it will proceed to take further action. However, it added that if firms send satisfactory replies, "the names of the companies would be dropped from the list". The regulator also requested the pharma associations to sensitise their members about getting price approvals before launching any 'new drug'.
List of formulation launched without price approval.