Team Blitz India
IN a strategic move to streamline its pharmaceutical sector, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has centralised the issuance of no objection certificates (NOCs) for the manufacture of unapproved, banned, or new drugs intended for export. This decision, aimed at boosting export efficiencies, marks a significant shift from the previous delegation of these powers to state licensing authorities.
India holds a prestigious position as the world’s third-largest drug producer by volume, catering to over 200 countries. The country is a cornerstone in the global vaccine supply, providing 62% of the world’s vaccines, including major contributions to the supplies of DPT, BCG, and measles vaccines. Approximately 70% of the vaccines under WHO’s essential immunisation schedule come from India.
The recent regulatory changes are expected to significantly influence the global generic medicine market, where India is a key player. With patents on drugs worth an estimated $251 billion set to expire over the next decade, India is preparing to capitalise on the surge of generic drug opportunities. Centralising the licensing authority could streamline processes, ensuring faster and more uniform approval for exports.
Quality concerns have prompted tighter control after various incidents, including severe health issues linked to contaminated medications traced back to India. In response, the government has enforced stricter manufacturing quality checks, resulting in licence cancellations for several companies failing to meet standards.
As the patents expire, the Indian generic drug market is poised for expansion, emphasising the need for strategic planning to facilitate the timely introduction of generic alternatives into the market. However, the industry faces hurdles like stringent intellectual property rights, research and development challenges, and the need to navigate complex regulatory environments.
Under the new directive, pharmaceutical firms are required to obtain NOCs from CDSCO’s zonal offices through an online system before seeking manufacturing licences from state or UT drug regulators. This shift is designed to eliminate bureaucratic delays and simplify the application process.
