Pharma cos should develop strategies to develop APIs and empower India: Dr Eswara Reddy


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In order to empower the Indian pharmaceutical industry for Active Pharmaceutical Ingredients (APIs) and Key Raw Materials (KSMs), Dr Eswara Reddy, Joint Comptroller General of Medicines India, urged industry stakeholders to develop strategies. He also stressed that the schemes announced by the government should be seen as an additional benefit and not as a primary criterion for setting up a facility.

During a virtual conference organized by ICN PHARMASCOPE: A Step Towards Atamnirbhar Bharat – Made In India, Made for the World, Dr Reddy said: “India imports almost Rs 42,000 crore APIs / KSM intermediaries. Considering that India is excessively dependent on China, the import of nearly 70% of API / KSM is of concern. API dependency will not only affect domestic requirements but also export performance. Therefore, self-sufficiency in the manufacture of API / KSM must be ensured.

Speaking about production-linked incentive programs (PLIs), he said the government has identified 58 API / KSMs for which the Indian pharmaceutical industry is heavily dependent on China. These imported APIs / KSMs are widely used for antibiotics, cardiovascular disease, vitamins, steroids, anticonvulsants, hormones, antiretrovirals, antidiarrheals and antibiotics. The government has identified the advantage of China over India in capacity, interest rate, cost of electricity, cost of effluent treatment plant (ETP), technology, etc., resulting in a total cost of production of 20-30%. less than India. Although the government has announced the PLI program, Reddy said that it is not possible for every company to benefit from it as there are various arrangements that will be given priority consideration, such as companies involved in integration in upstream, the adoption of new age technologies, etc. .

And according to data collected by customs for the period 2018-2019, the country imported a total of 699 APIs, including 378 from China and 321 from other countries.

Highlighting the delay in implementing the previously announced programs, Reddy said that due to the complexities of coordinating between various central government and state departments, they could not materialize.

While informing about the main characteristics of the PLI scheme application and the scheme selection criteria, he also explained the entirely new project, which is “a project in which a minimum threshold investment is proposed by the applicant in the under this regime in a new production facility, or in a new factory on the premises of an existing facility. Whereas, if the applicant is an existing manufacturer, he can use auxiliary installations namely; ETP, quality control laboratory, storage area and use for the manufacture of the eligible product. However, the investment already made in the ancillary facilities is not eligible for the purposes of the threshold investment.

Emphasizing the goal of bulk drug parks, he mentioned that the main goal is to lower the price of the formulation by at least 20 percent. And this will be possible when the state government puts in place common infrastructure such as common logistics (C&F, insurance, transport, etc.), an advanced laboratory test center including a microbiology laboratory and stability chambers. , an emergency response center, a common solvent storage system, solvent recovery, safety / hazard operations audit center, a center of excellence, mainly a regulatory awareness center, an incubator for technology companies, IPR management services, process / technology development lab, industry-university focal point and training center.

He also informed that of the three upcoming bulk drug parks, there will be a minimum of 450 units as each park will have at least 150 units.

Considering the warehouse which is an integral part of the pharmaceutical supply chain, government authorities plan to dedicate 500 acres of land in each bulk drug park to a common warehouse, which will be equipped with a cold store and d other modern technologies. related to the supply chain.

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