DPCO Current Affairs

NPPA notifies prices of 65 essential formulations

The national drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has notified prices of 65 essential formulations, including those used for treatment of diabetes, pain, infections and high blood pressure. The 65 essential formulations fall under scheduled I formulations under Drugs (Prices Control) Order (DPCO), 2013.

Key Facts

All manufacturers of scheduled formulations, selling branded or generic or both versions of scheduled formulations (drugs) at price higher than ceiling price as fixed and notified by Government, have to revise prices downward to the ceiling price cap.

Moreover, manufacturers of these 65 formulations have to furnish quarterly returns to NPPA through IPDMS (Integrated Pharmaceutical DataBase Management System). Besides, any manufacturer intending to discontinue production of any of 65 drugs has to furnish information to NPPA, with respect to discontinuation of production of drug or its import, at least six months prior to intended date of discontinuation.

National Pharmaceutical Pricing Authority (NPPA)

NPPA is independent body under Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers. It was set up in 1997. Its mandate is to fix/revise controlled bulk drugs prices and formulations, enforce prices and availability of medicines under DPCO, 2013.

NPPA fixes ceiling price of essential medicines of Schedule I under DPCO 2013. The calculation for essential drugs is based on simple average of all medicines in particular therapeutic segment with sales of more than 1%. In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10% annually.

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Government to constitute committee for drug pricing, new launches

The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers will constitute  multi-disciplinary committee of experts for consultation on matters pertaining to implementation of drug price control order (DPCO) including technicalities involved in pricing and new launches.

It will have member secretary of National Pharmaceutical Pricing authority (NPPA) as its convener. It will also have representatives from Central Drugs Standard Control Organisation (CDSCO), Department of Health Research/Indian Council of Medical Research (ICMR) and NIPER as members.

Background

The committee will be constituted taking in view of the experience gained from implementation of Drugs Price Control Order (DPCO), 2013 for consultation on all technical issues related to pricing, launch of new drugs with ancillary provisions where more clarity is required.

Key Facts

The committee is also mandated to recommend its opinion on claims of pharma companies about any additional therapeutic features associated with any formulation. It will also recommend separate ceiling price of scheduled formulations or retail price of any new drug with specified therapeutic rationale.

It will also give its opinion on claims of pharma firms about additional pharmacoeconomics features associated with any formulation/Active Pharmaceutical Ingredient (API). Besides, it will also give opinion on technical related issues such as whether a drug is scheduled or non-scheduled on basis of ingredients used in formulation.

It will give opinion on technical issues and claims by pharma companies about novelty associated with indigenous research and development of their products, for granting exemption from price control order for period of 5 years.

The recommendations of committee will considered by NPPA which will pass reasoned order on it. The committee will be empowered to invite or co-opt any other specialist depending on exigencies of circumstances requiring resolution of any specific matter arising out of implementation of various provisions of DPCO 2013.

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