How is the pharmaceutical sector in India being made more efficient?
In a significant development, the Central Drugs Standard Control Organization (CDSCO) of India has recently made a decision to centralize the authority for issuing No Objection Certificates (NOCs) for the manufacturing of pharmaceuticals intended for export. This move marks a departure from the previous practice where State licensing authorities were delegated the power to issue such certificates for drugs, including those that were unapproved, banned, or newly developed.
This regulatory shift comes amidst growing international scrutiny on the quality and safety of drugs exported from India. There have been allegations and concerns raised by various countries regarding the standard of pharmaceutical products originating from India, with reports suggesting instances of substandard drugs causing health complications in importing nations.
As part of this change, the CDSCO now assumes the sole responsibility for granting manufacturing licenses for drugs designated for export purposes. This consolidation of authority aims to streamline regulatory oversight and ensure stringent quality control measures are implemented throughout the production process.
India holds a prominent position in the global pharmaceutical landscape, ranking third in terms of production volume. The country’s pharmaceutical industry boasts a vast export network, supplying medicines to approximately 200 countries and territories worldwide.
One of the key highlights of India’s pharmaceutical prowess is its significant contribution to global vaccine supply. The country is a major player in the production of essential vaccines, including those for diseases like diphtheria, pertussis, tetanus (DPT), Bacillus Calmette-Guérin (BCG, primarily used against tuberculosis), and measles. Notably, India caters to a substantial portion of the World Health Organization’s (WHO) vaccine demand, with at least 70% of vaccines recommended under the essential immunization schedule sourced from Indian manufacturers.
This acknowledgment of India’s pivotal role in global vaccine supply underscores the importance of maintaining high standards of pharmaceutical manufacturing and regulatory oversight. By centralizing the authority for issuing manufacturing licenses and NOCs, the CDSCO aims to reinforce India’s commitment to delivering safe, effective, and quality pharmaceutical products to the global market, thereby upholding its reputation as a reliable pharmaceutical supplier on the world stage.
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