MUMBAI: The National Pharmaceutical Pricing Authority (NPPA) has issued a notice seeking explanation from 67 pharmaceutical companies found to be selling 201 new versions of essential medicines without government approval on their pricing, a statement released on its website late on Wednesday showed.
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, Wockhardt and Zydus Cadila, among others.
The move could result in penalties for several drugmakers, and is the latest in a series of recent actions by India’s National Pharmaceutical Pricing Authority (NPPA) towards tightening control of drug prices.
More than 300 medicines that India defines as essential are currently under a government price cap, and the law requires companies to seek approval of the NPPA before launching new dosage forms or combinations of such drugs.
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.
Accordingly it has been decided to take action against these companies, 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 added that if replies are not received by June 15, the regulator 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”.
NPPA also requested the pharma associations to sensitise their members about getting price approvals before launching any ‘new drug’.
For this check click on http://www.nppaindia.nic.in/
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