The production of Rifampicin, a key drug for treating serious bacterial infections like Tuberculosis, is expected to begin this year. The drug Rifampicin is used in serious bacterial infections, particularly Tuberculosis.
According to the official sources to ANI, “Rifampicin is at an advanced stage of execution and is expected to be commissioned later this year.” Rifampicin is the key drug used for the first-line treatment of tuberculosis.
“To effectively continue our goal of eliminating TB, consistent supply of essential first-line anti-tubercular drugs like Rifampicin is essential. During FY2023-24, India imported Rifampicin worth Rs 77 crore,” it added.
According to the ANI report, the other important drugs like Prednisolone, Betamethasone and Dexamethasone are also expected to be commissioned this year.
Prednisolone and Dexamethasone are used to treat asthma, allergies, immune disorders, etc. About 3.5 crore Indians suffer from asthma, and increasing air pollution is contributing to growing incidence. During the second wave of COVID-19, Dexamethasone and Methylprednisolone were also utilized in treating COVID patients; however, maintaining consistent supply posed a significant challenge. Betamethasone is used to manage labour in cases of premature childbirth, to improve the maturity of lungs in pre-term babies.
“Prednisolone, Betamethasone, and Dexamethasone are all part of the National List of Essential Medicines. Therefore, it is essential to secure India’s supplies for such medicines,” the source said “Under the PLI scheme for bulk drugs, Natural Biogenex Private Limited is establishing projects of 10-15 MT/annum capacities for Prednisolone, Dexamethasone and Betamethasone at Tumkur in Karnataka. At optimal production, the projects are expected to ensure annual domestic supply worth Rs150 crore, which will contribute significantly to India’s self-resilience in this key class of drugs, besides contributing to the domestic economy and foreign exchange savings,” it said.
On enhancing fermentation technology in bulk drugs through PLI scheme, the official source said, “Enhancing Fermentation Technology Capabilities in Bulk Drugs through the Production Linked Incentive (PLI) Scheme for Bulk Drugs. While the Indian pharmaceutical industry is the third largest in the world by volume and is USD 50 billion in terms of value, of which more than 50% is comprised of exports, India is import-dependent on certain bulk drugs, which are active components of finished medicines. Some of these medicines are essential medicines.”
“The vulnerability due to supply chain dependence was acutely felt during COVID-19. In line with India’s vision of Atmanirbharta, Government of India launched the PLI scheme for Bulk Drugs, with the objective of attaining self-reliance and reducing import-dependence in critical bulk drugs,” the source further explained as quoted by ANI.
“The plan of the government has begun to fructify, as is evident from completion of 34 projects under the PLI scheme for bulk drugs with over Rs 4,200 crores of investment, for production of critical Active Pharmaceutical Ingredients (APIs) or Key Starting Materials (KSMs) of APIs, on which India has been wholly or highly import dependent. These include Penicillin-G, KSM for several antibiotics, Clavulanic Acid, API for medicines used to treat antimicrobial resistant cases in conjunction with other antibiotics,” it said.
According to the experts, Fermentation-based projects are technologically more challenging to establish than chemical-based ones, and India has been significantly import-dependent in fermentation-based manufacturing of APIs.
(With inputs from ANI)
