ELP Pharma Track 1st Quarter 2017

The First Quarter of 2017 saw several announcements, policy statements and regulatory actions affecting the Pharma & Life Sciences Industry. While some immediate effects were seen as in the price regulation of Stents, the lasting effect of these changes will be seen in the coming months. The Medical Devices Industry is a key focus area in the National Health Policy, 2017 as well as in Government action in the First Quarter. India, which presently imports more than 70% of medical devices sold in the country, is expected to become a manufacturing hub of medical devices. The Medical devices Industry has been invited to participate in the Government’s “Make in India” initiative.

For the rest of the industry, Government Policy indicates further preferential purchase by the Government, further changes in the Drugs and Cosmetics Rules to promote the use of generic drugs, and changes in the clinical trial guidelines to promote transparent polices regarding patient compensation and an innovative
research environment.

It will be seen in the coming months how the Government maintains the balance between policies promoting the affordability of medicines and industry’s need for returns on investments. While increased access of people to healthcare is an imperative, increased price control will prove counterproductive for innovation, which will ultimately be to the detriment of patients in India. Knee jerk actions like enforcing regulations on doctors to prescribe drugs by their generic names may pose serious challenges. NPPA’s actions fixing the price of various drugs have faced review actions and innovator companies have considered withdrawing their products.

The First Quarter also saw efforts by the Government to digitise its systems to promote “ease of doing
business”. The judiciary in the meanwhile has been busy deciding the battles between the multinational innovator companies seeking protection of their Intellectual Property Rights on the one hand, and refusing to interfere with the approval granted by the Regulator for manufacture of a biosimilar drug, on the other.

The Judiciary has by far been able to set a well-reasoned standard, as well as maintain equilibrium of obligations under the TRIPS, Patents Act and the social interest of the country.Through this update, Economic Laws Practice (“ELP”) brings to you a summary of some noteworthy developments during January to April 2017. We hope you find this update useful.