POWERS FOR ISSUING NOC FOR EXPORT OF DRUGS

Copyright infringement not intended

Picture Courtesy:  https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/regulator-revokes-state-licensors-power-to-issue-noc-for-drug-exports/articleshow/109825473.cms?from=mdr

Context: The Union Government announced to centralize the authority for issuing manufacturing licenses and No Objection Certificates (NOCs) for certain categories of drugs meant for export.

Details

• The authority to issue manufacturing licenses and NOCs for the export of drugs has been transferred from state governments to the Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulatory body.

Key Changes and Implications

• Sole Licensing Authority: CDSCO will now be the sole licensing authority for new drugs intended for export purposes. This change aims to streamline the approval process and ensure uniformity in regulations across states.
• Timeline for Implementation: The transition to the new system will be effective from 15th May 2024 onwards, requiring pharmaceutical companies to submit fresh applications for NOCs directly to CDSCO zonal offices.
• Online Application Process: Applications for NOCs must be submitted online through the CDSCO's online platform (SUGAM), enhancing efficiency and transparency in the approval process.
• Withdrawal of State Authority: The delegated power of state/UT Licensing authorities to issue NOCs has been withdrawn, and all existing NOCs issued between 20th August 2018 to 14th May 2024 will be transferred to CDSCO zonal offices.
• Role of CDSCO Zonal Offices: NOCs will now be granted by the Head of respective CDSCO Zonal offices, facilitating a centralized and standardized approach to drug exports.

Significance

• Efficiency and Timeliness: The decision aims to address concerns raised by the Drug Consultative Committee (DCC) regarding the time-consuming process of obtaining NOCs from multiple state drug regulators, which could lead to delays in export consignments.
• Streamlining Export Procedures: By centralizing the licensing authority, the government seeks to simplify export procedures for pharmaceutical products and enhance India's competitiveness in the global market.

Recent Data released by the Commerce Ministry ●India's pharmaceutical exports increased by 9.67% year-on-year to reach USD 27.9 billion in FY24, marking a significant increase from USD 25.4 billion recorded in the previous fiscal year. ●The United States, the United Kingdom, the Netherlands, South Africa, and Brazil emerged as the top five export destinations for Indian pharmaceutical products during FY24. The US alone accounted for over 31% of India's total pharma exports. ●India's pharmaceutical industry is recognized as the third-largest by volume and the 13th-largest by value globally. It has a vast portfolio of more than 60,000 generic drugs across 60 therapeutic categories, highlighting the sector's breadth and depth. ●The government has introduced two production-linked incentive (PLI) schemes aimed at promoting domestic manufacturing of key pharmaceutical ingredients and generic medicines, highlighting its commitment to promoting the growth and competitiveness of the sector. ●Despite global economic challenges, India's pharmaceutical sector has demonstrated resilience and driven significant export growth in FY24. With a strategic focus on diversification, innovation, and domestic manufacturing, the industry is well-positioned to capitalize on emerging market opportunities and sustain its growth in the coming years.

Conclusion

• This development highlights the government's commitment to modernising regulatory processes in the pharmaceutical sector, aligning with broader efforts to promote ease of doing business and strengthen India's position as a leading exporter of pharmaceuticals globally.

Source:

Livemint

Indian Express

PRACTICE QUESTION Q. India is known as the "Pharmacy of the World" for its dominance in generic drugs. How can Indian pharmaceutical companies move beyond generics and establish themselves as leaders in innovative drug discovery, considering the challenges of high R&D costs, stricter regulations for new drugs, and competition from established multinational corporations?