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The Indian Pharma Regulatory System

The IndianPharmaceuticalsector has come along way, beingalmost a smallsector to a vitalsupplier ofhealthcare products,serving almost allthe pharmaceuticalsneeds of thecountry. Thepharma Industrytoday is in the frontrank of India’sScience basedindustries with wide

ranging capabilities in the complex field of drug manufacture and technology.

Indian Government is stringent on price control of pharmaceuticals and this becomes a

Nilesh Thosani

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The Indian Pharma Regulatory System

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Posted by Nilesh Thosani at 01:10

major hurdle for global players to enter in India. In-order to get the NOC for import of drugsit becomes very tedious for the companies to mark their presence in the Indian market. Forpermission to import or manufacture of new drug substances and its formulations formarketing in the country, applicant is required to file application along with a very longdocumentation process which doesn’t have a fixed time frame in which the application willbe reviewed and approved. For making the process a lot easier many consultants have cameinto being. Among these companies RIHIM Pharma Consultancy is well known whichfacilitates the global companies to penetrate in the Indian market. RIHIM is famous inassisting its clients with Import NOC related all the formalities which are required forintroducing any new Drug, Clinical research, machine or cosmetics. All manufacturing ofDrugs in India requires Licensing even for any such place where the drug manufacturing iscarried out the Licensing is required. Other than this the license has to be renewedperiodically. For all these License related efforts RIHIM is acknowledged as a prominentPharma Regulatory Consultant among all other prevailing advisers in India.

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