The price regulator says about 201 formulations have allegedly been found without approval.
New Delhi: If the rising cost of private healthcare wasn’t bleeding patients dry, the government has now found top pharmaceutical companies allegedly selling new medicines in the market without taking any approval from the government.
The National Pharmaceutical Pricing Authority (NPPA) is examining close to 200 cases of overcharging where companies may be asked to pay back the excess amount collected from the consumers. Major companies like Abbott, Biocon Ltd, Cadila Pharmaceutic-als, Dr Reddys, Glaxo-smithkline Pharma Ltd, Lupin Ltd, Mankind Pharmaceuticals, Ranbaxy Laboratories Ltd, Sanofi India Ltd, Zydus Cadila among others are in the dock for launching new drugs/formulations without applying for the price approval. The price regulator says about 201 formulations have allegedly been found without approval. The rules says manufacture are liable to deposit overcharged amount over and above the price notified by the government, with interest in case of penalty. In case of non-compliance, these companies may face prosecution.
The NPPA has also asked the companies to furnish batch-wise production and sale details with MRP certified by a chartered cost accountant for the formulations from the date of the launch of production along with reasons for non-compliance of the provision related to new drug in one month. “If the replies are not received by June 15, the NPPA will proceed for taking further action as per the DPCO 20133 and Essential Commodities Act, 1955.”
While, the NPPA has not sent individual show cause notices to the pharmaceutical companies, in their letter sent on Wednesday to the industry associations, pharmaceutical companies and the state drug controllers, the NPPA has asked the pharma industry association to sensitise the members to obtain prior approval of process before launching any formulation or a new drug.