Over 200 new drugs introduced in the market are under the Centre's scanner, according to an official order released by the National Pharmaceutical Pricing Authority (NPPA).
The order released by the drug pricing regulator lists several new combination drugs that have been launched recently by companies such as Abbott Healthcare, Cadilla Pharmaceuticals, Dr Reddy's laboratories, GlaxoSmithKline Glenmark, Novartis, Ozone Pharmaceuticals and Mankind Pharmaceuticals.
According to NPPA, these "new drugs" (mostly combinations) contain an altered formulation—the strength and dosage is not as specified in the Drug Price Control Order, (DPCO) 2013. In other cases, the companies have not sought price approval for these drugs.
"It is not clear whether these drugs have the approval of the Central Drug Standards Control Organisation, and whether these are rational or irrational combinations of drugs as many of these are fixed dose combinations," the order states. The companies have been asked to furnish batch wise production and sales details, and pharma associations have been advised to apply for price control before launching a new drug.
The order needs to be seen in the context of the Centre's push for "affordable" generic medicines versus branded medicines, and the accompanying controversy around quality of drugs. Doctors have been arguing that quality is often an issue, especially when it comes to combination drugs, where the formula has to be strictly adhered to. Hence, doctors say they rely on experience with various brands while writing prescriptions.
The NPPA order, however, raises several issues around how drug companies are able to circumvent norms around pricing and quality, and how tighter regulations might be required to ensure access to better quality drugs at affordable prices.
