Firms need to give 6 mth notice to stop making essential drugs
New Delhi: Pharmaceutical firms will have to issue a public notice and inform authorities six months in advance if they planned to stop production of any formulation of essential drugs, according to a government order.
The government can, however, ask the manufacturers to continue to produce required level of essential drugs in public interest, according to the Drug Price Control Order, (DPCO) 2013.
"Any manufacturer of scheduled formulations, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the Government...In this regard at least six months prior to the intended date of discontinuation," the order said.
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.
"Government may in public interest direct the manufacturer of the scheduled formulation to continue with required level of production and/or export as specified in the order for a period not exceeding one year from the intended date of such discontinuation within 60 days of receipt of such intimation," the DPCO said.
Further, drug makers will have to maintain records relating to the sales of APIs (Active Pharmaceutical Ingredients) and bulk drugs, manufactured or imported.
"The government shall have the power to call for any record or to inspect such records at the premises of the manufacturer," says DPCO, 2013.
Price control over drugs was first introduced in the country in the aftermath of the Chinese aggression by the Drugs (Display of Prices) Order 1962 and the Drugs (Control of Prices) Order 1963.
The drug policy of 1994 covers 74 bulk drugs under price control and it was implemented through DPCO 1995.