Updated on 14 May 2013
Indian life science is leveraging on increasing sales of generic medicines, continued growth in chronic therapies and greater penetration in rural markets
Leveraging on the back of increasing sales of generic medicines, continued growth in chronic therapies and a greater penetration in rural markets, the Indian pharmaceutical market is expected to register a strong double-digit growth of 12-to-14 percent in 2013, although the year 2012 closed with a growth of less than 10 percent, according to BioSpectrum Asia Top 20 Survey. The Indian pharmaceutical market has seen many policy initiatives, compulsory licensing, FDI policy, pricing policy, marketing code and regulatory approvals - from the regulatory agencies in 2012.
During 2012, through the Drug Price Control Order (DPCO), the National Pharmaceutical Pricing Authority (NPPA), cleared the National Pharmaceutical Pricing Policy 2012. Unlike the current cost-based pricing policy, this new policy is market-based, and seeks to control prices of all strengths and dosages of 358 drugs and their combinations that fall into the National List of Essential Medicines (NLEM). The price control will also be applicable to imported medicines, if these drugs also fall in the list of essential medicines.
Furthermore, the government is keen to promote indigenous research in the country. Original research products that have a patent in India will get exemption from price control for five years. The government is expected to come out with the new Drug Price Control Order (DPCO) in 2013.
The Controller General of Patents, Designs and Trade Marks, which is India's intellectual property office, had in March 2012, allowed Hyderabad-based Natco Pharma to make and sell the generic version of Bayer's patented cancer treatment Nexavar. This allowed Natco to sell generic version at three percent of the original medicine's price for a month's dosage. This has received mixed reaction from different state holders like industry, policy makers and NGOs.
Also, the Supreme Court in a landmark judgment ruled against Novartis in the Glivec case by rejecting its plea for the grant of a patent for its drug molecule, imatinib mesylate. Novartis had applied for a patent for the beta-crystalline version of the drug, on the basis of increased safety due to the modifications in the chemical entity, which was denied by the apex court on April 1, 2013.
Since last year, the Drug Controller General of India (DCGI) has withdrawn from its role of approving drug trials and has handed over the responsibility to a new Drug Advisory Committee (NDAC), which has approved only nine drugs for clinical trials, according to a PwC report. Due to frequent regulatory delays, rise in the costs of conducting trials, India is losing its feasibility as a cost-effective destination to conduct clinical trials as compared to many countries. According to reports, new drug approvals dropped by over 50 percent during 2011 to 98 from 224 in 2010.