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The entire medical devices industry will be brought under full regulation by October, according to Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).
Speaking to newspersons on the sidelines of the inaugural session of the 9th International Pharmaceutical Exhibition (iPHEX) being organised by the Pharmaceuticals Exports Promotion Council (Pharmexcil) here today, the official said 50 percent of the medical devices (two out of total four categories) is already under regulations.
When asked about other initiatives being taken, he said certain amendments to the Act are being discussed.
Earlier, while speaking at the inaugural session, Raghuvanshi said medical devices offer the next big opportunity for India as current business in this segment is only 1.5 per cent of global trade at $11 billion.
Quality is core for the Indian pharma industry to capitalise on the huge opportunity in the global market. The size of the Indian pharma industry (both exports and imports) now stands at about $50 billion and this is expected to reach $100 billion, the DCGI said.
The core of this huge opportunity depends on quality and it is possible to triple the turnover of many companies if this is taken care of, he said.
Indu Nair, Joint Secretary, Department of Commerce, said the government is focusing on many aspects including building a strong supply chain and robust regulation. The Product Linked Incentive (PLI) scheme which has the production of 53 key Active Pharmaceutical Ingredients (APIs) under its ambit would go a long way for the pharmaceutical industry, officials said.
Addressing Non-Tariff Barriers (NTBs) for pharma exports are also being taken up with various countries along with discussions for Free Trade Agreements, she added.
S V Veeramani, Chairman, Pharmexcil said India’s pharmaceuticals exports stood at $25.4 billion during the FY 2022-23 and there is greater scope for further growth.
Ravi Uday Bhaskar, Director-General, Pharmexcil said most of the G20 countries were highly regulated and it is important for Indian industry to proceed in that direction while taking into consideration the new opportunities coming up in areas such as biopharma. “If we continue to manufacture only conventional generics, then the future is going to be challenging,’‘ Bhaskar added.
iPHEX, which is being organised with a special focus on India’s G20 Presidency this year, is being attended by representatives of industry and governments from about 100 countries.
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