The government of India is committed to back the pharma industry to improve the sector in a big way both domestically and globally, said Sudhanshu Pandey, joint secretary, department of pharmaceuticals (DoP). He was sharing his thoughts at the CEO’s Conclave organised in Hyderabad as part of the Pharmexcil’s 11th Annual Meet.
“The government of India is committed to back the pharma sector in all its ways. We are taking up various initiatives to not only improve the domestic API industry, but also encouraging the industry to improve exports in a big way. There are about 19 pharma SEZs in various stages of development and a few more clusters are in the planning. Very soon we are about to come out with a draft policy announcing various incentive for encouraging the pharma sector in the country,” Pandey said.
When asked about rising cases of US FDA warnings against the Indian pharma industry in the recent past, Pandey replied, “If we look at a pro-rata basis, given the number of US FDA approved plants in India, these warning letters issued to Indian companies are less compared with US based companies. Therefore there is no need to be worried about the warning letters. The Indian industry is robust and has set its own standards that are ratified by WHO GMPs, the world's highest body. In fact we can say we are in a transition stage and needs to improve a lot to compete with the global players on a continuous basis and the government is always behind the industry to help it.”
Currently the scrutiny for Indian players has become tougher in the global market. The recent GVK Bio issue regarding allegations by the French inspectors about the data integrity and falsification of the data by the company has hampered the entire pharma sector in a big way. In view of this, the CDSCO has also taken a strong note of this issue and conducted inspections of the GVK Bio plants in the country. At the same time, the Indian government has also set up various committees to looking into the allegations of falsification of the data.
“We have sent our inspectors to look in to the allegations and conducted the inspections of the GVK Bio, but did not find any evidence to support the evidence. This itself shows there is a deliberate attempt to malign the image of the Indian pharma industry. We will stand by the our industry and fight against any such attempts to defame our industry,” replied Pandey to a question of data integrity and falsification of bioequivalence studies by GVK.
According to Dr P V Appaji, Director General of Pharmexcil, the Indian pharma industry is undergoing a rapid transition stage. With growing competition across the globe, there have been lot of regulatory changes happening internationally and obviously the Indian pharma industry is targeted deliberately to contain its proliferation. In the coming days, India is sure to become the global hub for the pharmaceutical and biotechnology research. “Our goal is to make India a global hub for international companies to do their research and contract manufacturing here in India. This year there is a slowdown in the API exports but the formulations have picked up,” Appaji said.