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Experts call on industry associations to join hands with govt to develop centre of excellence for MSMEs

Laxmi Yadav, Mumbai
Monday, December 20, 2021, 08:00 Hrs  [IST]

Experts have called on drug industry associations to work with micro, small and medium enterprises (MSME) department to develop centre of excellence for MSMEs which helps them build global competitiveness and harness manufacturing excellence.

“MSMEs are the backbone of pharma and attention is needed to nurture this. Six major and 12 mini platforms have been identified. Each platform requires a centre of excellence to support MSME and even large pharma and a cluster to integrate the efforts.Example, isolated efforts in flow chemistry, fluorination chemistry and biocatalysis could be very expensive. We need a national effort. Chemistry, the route of synthesis can help only a few percentages in cost in old drugs but the infrastructure and quality laboratories cost are prohibitive for MSMEs. They lack adequate resources to adopt latest technologies to achieve manufacturing excellence and initiate R&D,” said Lanka Srinivas, senior advisor, Pharmexcil and technical committee member-production linked incentive (PLI) scheme for pharmaceuticals.

“We need shared infrastructure for MSMEs. We need centre of excellence for them. Each state should look at developing such parks for MSMEs with or without the support of the central government. Industry associations should work with MSME department to develop centre of excellence for MSMEs,” he stated.

MSMEs need these technologies. They cannot develop these on their own. Scheme for innovation needs to be funded on milestone basis involving universities, government institutes and private sector is urgently required. Industry needs to work with the government on lease models, pay per use models, getting international agencies funds, said Srinivas.

A lot of water has flown over the last five years. India’s active pharmaceutical ingredient (API) dependence is replaced with only intermediates dependence. For example, country’s pharma market is approximately USD 50 billion. API consumption is estimated around USD 16-18 billion. API exports stood around USD 4 billion. Currently, India’s API dependence on offshore is just 15 per cent. The market opportunity, awareness, government interventions have mitigated the risk significantly in APIs. However, we depend on offshore for drug intermediates. Now this has become a significant challenge. The drug intermediates manufacturing is a key ingredient in PLI. Hence a lot more will get mitigated in five years, he added.

Discussions have been going on since last decade about India's dependence on China in active pharmaceutical ingredients. To address this, the government has come out with two PLI schemes.

Earlier, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) had conducted a study with the support of Union ministry of commerce and industry on how to reduce the import dependence on China and to make the India self-reliance in pharmaceuticals to some extent. Prof Javed Iqbal and Lanka Srinivas were part of the study group along with 150 eminent scientists from national research institutions- CSIR, IITs, IISc and 100 representatives from industry. Based on the report of the study group, the two PLI schemes worth Rs. 21,940 crore were introduced by the government which received a positive response from the industry.

The Department of Pharmaceuticals (DoP) has recently announced the list of all 55 applicants selected to set up manufacturing facilities under the PLI scheme for pharmaceutical sector with a total quantum of Rs. 15,000 crore incentive.

The scheme has received a total of 278 applications by the closing date of August 31, 2021. It covers three different product categories: Category 1 with biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, cell based or gene therapy drugs, orphan drugs, special empty capsules like HPMC, Pullulan, enteric etc., complex excipients and photo-pharmaceuticals; Category 2 with APIs, key starting materials and drug intermediates among others; and Category 3 under which drugs not covered under the other categories are covered, including repurposed drugs, auto immune, anti-cancer, anti-diabetic, anti-incentive, cardiovascular, phychotropic and antiretroviral drugs, in vitro diagnostic devices and others.

The scheme aimed at boosting India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector.

Earlier the DoP had launched Rs. 6,940 crore PLI scheme for promotion of domestic manufacturing of critical key starting materials or drug intermediates and APIs.


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