...sold through e-commerce channels. The new regulation came after amendment to the Legal Metrology (Packaged Commodities) Rules published by the Department of Consumer Affairs earlier in June. In March, India’s... Read More
In a series of moves to crack down on the overpricing of medical devices, India’s National Pharmaceutical and Pricing Authority (NPPA) has announced plans to establish a pricing scheme for... Read More
...were interested in proceeding. Ultimately, our client decided to look outside of India because they felt that there were too many issues associated with manufacturing their product in India. We... Read More
India’s main regulatory body, the Central Drugs Standard Control Organization, plans to hire as many as 250 new inspectors in 2017 in order to improve the safety and efficacy of... Read More
Recently, Prime Minister Narendra Modi’s Ministry of Health published a 108 page notification on medical devices in India. Significant changes to medical device regulations include: Device licenses will no longer... Read More
... Table of Contents: Regulatory Framework in India FDC Registration Process in India The Market Application Review Process Import Registration Process BE Study in India CDSCO Inspections Pharmacovigilance Plan Drug... Read More
In mid-February 2017, India’s National Pharmaceutical Pricing Authority (NPAA) fixed the price of drug eluting stents at $450 and bare metal stents at $110 USD. The NPAA may look to... Read More
In late January, 2017, India’s Central Drugs Standard Control Organization (CDSCO) finally released Medical Device Rules, which establish different regulatory norms for medical devices and drugs. For over 10 years,... Read More
The Indian drug price regulator, the National Pharmaceutical Pricing Authority (NPPA) proposed in January 2017 to categorize stents into two categories: drug-eluting stents (DES) and bare-metal stents (BMS). Along with... Read More
In India, 90% of clinical trials over the past few years have ended abruptly primarily due to contract research organizations (CROs) and drug companies using Indian patients as “guinea pigs”.... Read More