New Delhi:<\/b>\u00a0Global pharmaceutical giants are pushing the Central Drugs Standard Control Organisation (CDSCO) for faster approvals by granting parallel market authorisation that will allow drugs and innovative therapies to be marketed in India at the same time as in the US and Europe.\u00a0\u00a0<\/span><\/p>\n According to the Organisation of Pharmaceutical Producers of India (OPPI), which is lobbying for the move,\u00a0such approvals will help minimise the time gap between the introduction of drugs internationally and in India. OPPI represents major research-based pharmaceutical companies in India, including international giants such as Pfizer, Roche, Bayer, Merck, Novo Nordisk, and Novartis.<\/span><\/p>\n Under India\u2019s drug regulatory approval norms, clinical trial waiver for innovative drugs that have been licensed in the country of origin and developed markets is permitted. But the CDSCO has rarely permitted any drug to be launched in India without local clinical trials.<\/p>\n As a result, crucial breakthrough therapies against many diseases are available in India only 18 months or even 3-4 years after they are launched in developed countries.<\/p>\n There was however an exception during the peak COVID-19 pandemic, when several drugs including favipiravir and paxlovid were granted emergency use authorisations in the country without phase-wise clinical trials.<\/p>\n \u201cOur ongoing discussions with regulatory agencies underscore the necessity of a transparent and consistent regulatory pathway, facilitating timely access to cutting-edge therapies for patients in India,\u201d<\/span>\u00a0OPPI\u2019s<\/span>\u00a0director general Anil Matai told ThePrint.\u00a0<\/span><\/p>\n According to Matai, the network is working towards ensuring regulations supporting the simultaneous filing of marketing approval applications that align seamlessly with major global markets.\u00a0<\/span><\/p>\n \u201cWe are dedicated to creating a significant shift, positioning India as the preferred destination for Phase 3 studies and global clinical trials, ultimately reshaping the healthcare landscape to prioritise agility and patient-centered care,\u201d he said.\u00a0<\/span><\/p>\n However, industry experts told ThePrint that even though norms allow for faster approvals, the regulatory body is often \u201cultra-cautious\u201d while approving innovative drugs in the country.<\/span><\/p>\n Rajeev Singh Raghuvanshi, the drug controller general of India who heads the CDSCO, said that if such a representation has been submitted, the drug regulatory agency will evaluate it. \u201cWe will see what can be done within the ambit of norms,\u201d he told ThePrint.\u00a0<\/span><\/p>\nNorms permit fast approval but regulator \u2018cautious\u2019<\/b><\/h3>\n