CRAMS and dossier submission put Indian pharma on the global market spotlight: Suresh Khanna
Indian pharma’s mainstay in the areas of CRAMS (contract research and manufacturing services), product development, regulatory protocol adherence, and dossiers submissions in the required CTD (Common Technical Document) format are big growth opportunities, said Suresh Khanna, chairman, Karnataka Drugs and Pharmaceutical Manufacturers Association and designated partner, Dossier Solutions LLP .
There is a huge talent pool armed with skills of clinical studies, clinical data management, technical data writing, medical writing and coding which requires ample skill sets in information technology. Therefore, there is scope for significant growth in these pharma services from India to the global markets. The biggest advantage that stands to gain is the pool of English speaking professionals. This is attributed to the pharmacy and biotech education in the country. This segment of the pharma industry has proven its reliability in terms of turnaround, he added.
The qualified candidates are able to convey technical health-related information accurately and guide companies to comply with regulatory guidelines. This is the future for Indian pharma. The sector cannot face dearth of talent as there are good job prospects in the country. Moreover there are a slew of global pharma services companies that have made an entry into India. Their success will goad many more such international companies to foray into the Indian market. So it is not only Indian pharma’s excellence in manufacture but the ability to deliver related services that it is biggest advantage of our industry, said Khanna.
The industry can make its presence felt with the export of pharma manufacturing equipment like for tablet, form filling, air handling units etc and packaging equipment. The pricing of these will lure developing countries including Bangladesh to opt for India’s cost effective and high quality equipment. There is a big demand for this in the developing world. Indian companies have invested extensively to manufacture this indigenously, he said.
In the case of APIs (active pharmaceutical ingredients) being indigenously manufactured, bulk drug parks and the production linked incentive (PLI), have enabled companies to expand operations and increase growth prospects. India will be self-sufficient in APIs in a couple of years and the backward integration was much wanted and a step in the right direction. In formulations, there are no issues, but the ready access to API was the challenge encountered by the industry especially the MSMEs. So backward integration for APIs is the goal post for Indian pharma, Khanna told Pharmabiz.
Despite these incidents like the Gambian tragedy and the voluntary recall of the spurious ophthalmic drops, India is recognised for its manufacture of high quality medicines. With the highly qualified and experienced pharma workforce, there is no doubt that the industry will hold the fort to continue its adherence to high quality standards and good manufacturing practices. Every year the number of companies certified successfully by the strict global regulatory authorities only goes to reaffirm that standards of manufacture are notably appropriate, he noted.
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