The much-debated Draft Pharmaceutical Policy which was discussed in closed door meetings through last year may not see the light of the day after all. Jai Priye Prakash, Secretary, Department of Pharmaceuticals (DoP), told BusinessLine on the sidelines of a conference that the impending amendment to the Drug Price Control Order (DPCO), 2013, as obviated the need for a policy. The policy, which addressed a host of issues including limiting the role of the National Pharmaceutical Pricing Authority in fixing drug prices, and delegating the authority to draw up the National List of Essential Medicines to the DoP instead of the Ministry of Health, had attracted widespread criticism.
Sources in the DoP said the amendments to the DPCO include not bringing orphan drugs like Myozyme and Fabrazyme, which are used in the treatment of rare genetic diseases under price control, as it will discourage their indigenous or generic production. Currently, orphan drugs are hard to access and are mostly imported at a huge cost. The draft policy had said that patented medicines will not be subjected to price control, and the emergency powers under Paragraph 19 of the DPCO (to fix the ceiling price or retail price) can only be invoked by the DoP. This move was criticised as certain drugs including those used in the treatment of cancer are patented, and hence, extremely expensive. They are also outside the ambit of price control.
Gazette notification coming
However, it is still unclear how the DPCO will be amended. A query filed under the Right to Information (RTI) Act regarding impending changes to the DPCO filed by BusinessLline revealed that the DoP had held one meeting with government think-tank NITI Aayog on August 22, 2017 to deliberate changes in the DPCO. “No formal minutes of the said meeting were issued,” the DoP stated in its reply to the query. “Basis recommendations of NITI Aayog, we have approved changes in the DPCO. We have taken some recommendations into consideration while some have not been considered,” Prakash said. DoP sources also said that a gazette notification on the amendments will be issued by this month. However, the secrecy around NITI Aayog’s recommendations is intriguing, as the DoP has refused to respond to an RTI application seeking a copy of the same. “The information is denied under Section 8 (I) of RTI Act since the matter is still under consideration,” the DoP reply states. – The Hindu BusinessLine