Face regulatory delays, mull shifting overseas
Grappling with regulatory delays, several Indian pharma companies are looking to set up manufacturing facilities outside the country.
“Top pharma companies threaten to remain Indian only on papers, shifting their revenue, production and intellectual property base to friendlier and supportive countries,” Aditya Berlia, founder and president of Apeejay Stya Education Research Foundation, said.
Pharma firms say there is an urgent need to improve processes for clinical trials and drug approval in the country. The lack of a clear road map and regulatory delays have a financial impact on companies that are increasing research and development (R&D) expenses and expand product portfolio. “We want clinical trial process to have a defined timeline. At present, there is no timeframe,” says Anil Parekh, the president of medical affairs and clinical research at IPCA Labs.
Kavita Khanna, director of Bharat Serums and Vaccines, says clinical trial requires significant investment of resources, and lack of clarity leads to uncertainty and delays. “We need clarity on the regulatory pathway of clinical trials before starting the process,” Khanna said.
A former deputy drug controller of India says the lack of a conducive ecosystem to support advanced clinical trials is stoking companies to explore the option of setting up manufacturing units in foreign lands. “The atmosphere is not conducive for clinical trials. The regulator is quick to halt trials on the basis of limited understanding of the subject. Besides, there is a need for training and building a harmonised system to support clinical trials,” the former deputy drugs controller said.
The ability of companies to launch new molecules hinges on speedy regulatory review. At present, the Drugs Controller General of India (DCGI) reviews applications and later refers the same to the New Drugs Advisory Committee that sends its recommendations to the Technical Committee, and after approval from the Apex Committee, the application gets final clearance. The entire process can at times stretch to 18 months.
“The Indian pharma industry deserves its Mangalyaan moment and this can happen with an empowered regulator,” Khanna adds. Biocon, India’s largest insulin maker, has invested over $160 million to set up a bio-pharma manufacturing and research facility in Malaysia and has started recruiting employees. Biocon says Malaysia offers a state-of-the-art biotechnology ecosystem. “Biocon’s Malaysia facility will further augment its capabilities to cater to the global needs of diabetic patients for affordable insulin and insulin analogs,” it says.
Experts say that many countries have the requisite expertise in setting up automated manufacturing practices that depend more on technology than labour. Moreover, the ease of doing business in industry-friendly nations has attracted pharma companies to evaluate opportunities outside India in countries like Thailand, Malaysia and the UAE. “We are looking to invest around Rs 100 crore towards a facility in Abu Dhabi.
There are no long-drawn regulatory approvals required as long as we do not sell in the local market,” said an industry executive.