The Supreme Court had directed Union of India to bring all life saving and essential drugs under price control (quoted in National Pharmaceutical Pricing Policy, 2012). Number of orders have been made regarding price control in the Supreme Court and the matter was scheduled for final hearing on November 9, 2016. But, ironically, Secretary of Department of Pharmaceuticals (Ministry of Chemical), DIPP (Ministry of Commerce) and Ministry of Health had a meeting in October 2016 at Niti Aayog under the chairmanship of CEO Niti Aayog Amitabh Kant to undermine drug price control and abolish the National Pharmaceutical Pricing Authority (NPPA) and to delink National List of Essential Medicines (NLEM) from Drug Pricing Control Order (DPCO).
Read full legal-notice-for-contempt
Following are the extract of the leaked minutes of the meeting:
1. The DPCO should be delinked from the NLEM. The NPPA in its present form may be wound up and deployed in the dept of pharmaceuticals and the right to regulate prices should be vested with the government.
2. Approval for manufacturing marketing or selling any single ingredient drug would be given in salt name only. Labelling requirements to be changed accordingly. The trade name i.e. the brand shall be registered by the Trade Mark Registrar only after clearance from the DCGI.
Period of approval of any new drug shall be for 10 years in place of present 4 years. Explanation to rule 122 of drug rules would be amended accordingly. The explanation below Rule 122E to be suitably amended to the effect that a new drug shall continue to be considered for 10 years as ‘new’.
Before permission to manufacture a drug is given to by centre or state drug regulator, the application in his/her application will have to declare that no existing patent rights are infringed. The form for manufacturing permission under drug rules will be modified according to it. It was decided that the column relating to patent status of the drug in form 44 can be considered for deletion.
DCGI should strengthen and set up comprehensive database management system with facility of reports of product wise manufacturers and manufacture wise products, quantities produced and availability.
Schedule M to be amended as per WHO GMP guidelines.
3. The process of approval of new drugs is cumbersome as per Niti Ayog. CDSCO should take steps for timely approval……
4. MoHFW to notify devices rules by 15th Nov prepared by Niti ayog and department of pharma
5. Issue of renewal of licenses to be re-examined in consultation with the CEO of Niti Ayog