The new Drug Price Control Order (DPCO) has provided ample provisions to stop the pharma companies from discontinuing the manufacture of scheduled formulations. These clauses are provided to dispel the fears that cheaper essential drugs may be phased out after DPCO comes in effect.

“The Government shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation and the manufacturer of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation shall furnish the information as stated in Form-III of schedule-II of this Order quarterly,” according to DPCO 2013.

“Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the Government in Form-IV of Schedule-II of this order in this regard at least six month prior to the intended date of discontinuation and the Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production or import for a period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation,” it says.

The DPCO, which prevents the dealers or retailers from denying the sale of scheduled drugs without sufficient reasons, also asks the manufacturers to put maximum retail price not exceeding the ceiling price (plus local taxes as applicable), both in the case of scheduled and non-scheduled drugs.

The DPCO also empowers the authorities to inspect the premises of the manufactures who are supposed to maintenance of records and production thereof for inspection. “Every manufacturer shall maintain records relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the Government and the Government shall have the power to call for any record and to inspect such records at the premises of the manufacturer,” it says.

“Any Gazetted Officer of the Central Government or of a State Government, as the case may be, authorised by a general or special order by the Central Government or by the State Government, as the case may be, in this behalf may, with a view to securing compliance with this Order or to satisfy himself that the provision of this Order have been complied with,” it says.