Saturday, December 19, 2020
Collection Introduction: Dr. Milind Antani, Darren Punnen and Shreya Shenolikar of Nishith Desai Associates have analysed the important thing laws relevant to the Indian pharma, medical gadget and health-tech business in a multi-part podcast sequence. The sequence begins off with the fundamentals of pharmaceutical and medical gadget regulation and subsequently delves deeper into the regulation of assorted elements of the business. Every episode begins with an outline of relevant regulation, how the regulation applies to the business and ends by offering some sensible inputs on how stakeholders ought to strategy this house.
Episode Introduction: On this podcast, Darren Punnen, senior member of the pharmaceutical and lifesciences observe at NDA, supplies an outline of how each facet of the pharmaceutical and medical gadget business is regulated. This contains the scientific trial, manufacture, import, packaging and sale of medical units. He additionally covers ancillary drug regulation such because the drug worth management laws, the drug commercial laws and the laws relevant to healthcare practitioner in as far as they impression pharmaceutical and medical gadget corporations. A few of the legislations lined embody:
Medication and Cosmetics Act, 1940 which governs the scientific trial, import, manufacture, labelling and sale of medication and medical units.
The Authorized Metrology (Packaged Commodities) Guidelines, 2011 which govern the labelling of medical units.
Medication and Magic Cures (Objectionable Ads) Act, 1954 which regulates the advertising and marketing of medication and medical units.
The Uniform Code of Pharmaceutical Advertising and marketing Practices which regulates the way by which pharmaceutical and medical gadget corporations might market their merchandise to healthcare practitioners.
The Indian Medical Council (Skilled Conduct, Etiquette and Ethics) Laws, 2002 which regulates how allopathic practitioners work together with pharmaceutical and medical gadget corporations.
Medication (Costs Management) Order, 2013 which regulates drug pricing.
Proposed laws to control digital well being applied sciences in India.
Darren additionally supplies a quick overview of the enforcement authorities chargeable for administering the above-mentioned legislations.
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