15 Apr 2013, BioSpectrum Bureau , BioSpectrum
New Delhi: The Indian Drug Price Control Order (DPCO) 2013 highlighted that pharma companies need to issue a public notice and inform authorities six months in advance, if they plan to stop manufacturing of any essential drugs.
Moreover, the government can force the drug maker to continue producing the required level of essential drugs in public interest for a period one year from the intended date of discontinuation.
The National Pharmaceutical Pricing Policy 2012, which would bring 348 essential drugs under price control, was notified by the government on November 22, 2012. The DPCO 2013, which would replace DPCO 1995, is most likely to be notified by the government in April.
Furthermore, drug makers will have to maintain records relating to the sales of active pharmaceutical ingredients (APIs) and bulk drugs that are manufactured or imported. DPCO 2013 also pointed out that the government shall have the power to call for any record or to inspect such records at the premises of the manufacturer.