The Central Government in India has recently drafted legislation to ensure quality control of vital life-saving medical devices such as endoscopes and pacemakers. Drafted by the Sree Chitra Tirunal Institute... Read More
India’s National Pharmaceuticals Pricing Authority (NPPA) has recently introduced an online e-filing system for applicants wishing to apply for pricing or revised pricing of their medical product. The price list... Read More
Introduction For a long time, India was closed to many foreign markets through government protectionism and a nationalistic tariff system. Today, however, India is ripe for market entry for many... Read More
India’s National Pharmaceutical Pricing Authority (NPPA) has issued new regulations on drugs not currently under the mandatory price control list. These drugs are referred to as “non-scheduled formulations” and are... Read More
Currently, India has only just begun to address medical devices as a separate regulatory category. Generally, regulation of medical devices is only conducted by officially classifying certain devices as “drugs”... Read More
The Government of India’s Union Cabinet has approved the establishment of the Central Drugs Authority of India. This Authority would be an autonomous organization under the Ministry of Health &... Read More
...exports and also to manufacture in India. India has some high quality manufacturers and cheaper labor costs which encourage manufacturing there. Medical software is another area India should excel in.... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has recently passed new regulations on global clinical trials. The regulations are based on a meeting held in October 2006, which brought together... Read More
...quality assurance, and recording of data have not been established. Despite optimism over India’s cost-effectiveness, intellectual property (IP) protection remains weak in India. Until 2005, India issued patents simply for... Read More
On March 1, 2006, a set of guidelines on the import and manufacture of medical devices, issued by the Drug Controller General of India (DCGI), became effective in India. (Subsequently,... Read More