India Russia in process of liberalising new drugs registration
New Delhi: India and Russia are in the process of liberalising registration of new drugs in order to boost bilateral trade in pharmaceutical sector, a government official said Tuesday.
"A memorandum of understanding for facilitating a mutual, quicker and easier registration for drugs and pharmaceutical products between India and Russia is in the pipeline," Joint Secretary in the Department of Pharmaceuticals Raja Sekhar Vundru said.
Earlier in 2010, India had also signed an MoU for cooperation in pharma trade and industry with Russia and in order to implement the MoU, both the parties are working to set up a task force to exchange knowledge and views, he added.
The Russian pharmaceutical market is estimated to be around USD 18 billion in 2010. Due to lack of locally manufactured products, the country heavily depends on imported drugs.
As per estimates, India has a meagre share of 3 percent of the total USD 12 billion drugs that Russia imports.
At present, Indian pharmaceutical companies face various problems, such as lengthy process and non-acceptance of clinical trials data generated from outside while registering their drugs in Russia, industry experts said.
Ranbaxy Global Pharmaceuticals Business (President) Rajiv Gulati said: "Registration process in Russia has become very onerous and unrealistic ... They insist for repeating clinical trials, which leads to delays in registering new products."
Currently, it takes around three years to register a product in Russia, he added.
"If the clinical trials data has been accepted by US Food and Drug Administration, Russia should also accept it," Gulati added.
According to official sources, Indian pharma industry is interested in supplying 57 strategically identified medicines to Russia.
As per data available with the department of Commerce, bilateral trade with Russia in the last fiscal witnessed an increase of 21 percent and stood at USD 6.4 billion.
Pharmaceutical products, electrical equipment and tea were among the major products which were exported from India to Russia in 2011-12.
The Indian pharmaceutical industry is estimated to be a Rs 1 lakh crore industry, of which about Rs 48,200 crore is from the domestic market and rest from exports.