The Union government should have included state drugs controllers in the single multidisciplinary committee of experts which was constituted recently for consultation of all technical issues on pricing, said Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW and CDSCO and former Karnataka state drugs controller.
“This is because the state drugs controllers are the critical implementation authority for pricing consultations and approval of new drugs”, he added.
Although the DPCO 2013 has made provisions for technical issues related to pricing under para 15(1), yet this specific government order for the constitution of a committee is a good move and must be appreciated. India is globally the fourth largest by volume for pharmaceutical production and 13th in value. Now all this is achieved because of the approval of drugs in a streamlined manner by the state drugs control departments across the country. Therefore, the government should have considered the inclusion of the state drugs controllers because their expertise in implementing pricing as per DPCO cannot be overlooked, said Dr. Jagashetty.
Nevertheless the government should have selected at least one or two state drugs controllers. The government order for the formation of a committee comprising of experts will bolster the drug marketing and boost domestic production, he said.
But when it comes to actual practical problems in pricing and launch of new drugs it is the state licensing authority that has the knowledge and expertise to tackle and sort out issues for seamless high quality drug distribution, said Dr. Jagashetty.
When the government in its committee of experts appointed a member secretary from National Pharmaceutical Pricing Authority(NPPA), representative from the CDSCO (Central Drugs Standard Control Organisation), scientists from the Department of Health Research and Indian Council of Medical Research besides a pharmacoeconomics expert from the National Institute of Pharmaceutical Education and Research (NIPER) to review and approve drugs and medical devices, the absence of the state licensing authority personnel is conspicuous, noted Dr. Jagashetty.
Even in the Drugs Technical Advisory Board (DTAB) there is a state drugs controller who is a representative. In fact, the DTAB has the presence of two or three state drugs controllers on its panel of experts. So the government should have included at least one or two state drugs Controllers, he said.
Coming to government order which has a dedicated section on the Terms of Reference (TOR) of the committee, Dr. Jagashetty said that the panel of experts was only a recommending authority for the separate ceiling price of scheduled formulations and to deliberate on the pharmacoeconomic features associated with the formulations and active ingredients.