Drugs in India are regulated by the CDSCO and the NPPA. The CDSCO monitors clinical trials, regulatory approvals, import / export and quality control for pharmaceutical products, whilst the NPAA is involved in the price regulation for pharmaceuticals in the Indian market.

The National Pharmaceutical Pricing Authority (NPPA) has set up a pharma data bank which requires all pharmaceutical companies to provide information on pricing, production, sales and import of formulations. The purpose of this data bank would be to generate reports, educate consumers and facilitate transparency in treatments and costing.

The NPPA has decreed that non-submission of the information would be harmful to public interest. The deadline to register with the pharma data bank is 15 December 2015.

Talks are underway to introduce similar systems for medical devices in India. Currently medical devices are also regulated by the CDSCO and regulatory approvals can take anywhere between 6 – 9 months in terms of time frame. Detailed Timelines of the CDSCO can be found here. It would be of interest to watch this space to learn more on how the ever changing landscape for drugs and medical devices will effect your business for the Indian Healthcare industry.