Regulatory Partners And Their Dealings In Different Sectors

There has been a significant rise in the demands of the Indian market. Imported quality products are gladly welcomed in sectors like the cosmetics, food, medical devices etc. Now people are willing to pay more for better products and services and with the liberalisation of the rules and regulations which govern the import and export of goods into and from India, severalglobal companies and brands find India a very lucrative market.

But in order to ensure that the import of qualitative products especially where food, cosmetic, medical devices etc., are concerned, the Indian government has come up with certain legal requirements which have to be fulfilled in order to do business in India. While these rules, regulations, registration processes, procedures for application of licenses etc., are not very complicated to understand, they are cumbersome to deal with, especially for people not well-versed with the workings of the Indian Governmental agencies.

Hence in order to ensure smooth sailing for global brands and manufacturers when they want an entry into the Indian market, many companies have come up which offer consultancy services both in India and abroad. In fact these consultants are also equipped and knowledgeable about the workings of the corresponding Government agencies in countries out of India. Thus they not only facilitate a smooth entry for global companies into India, they also help Indian companies to make successful forays into the global market.

These consultants who call themselves Regulatory partners offer services in a number of sectors like:

  • Drugs wherein both manufacturers and importers are provided with proficient services of Pharma regulatory consultant India to hand hold them through the essential dossiers required to apply for licenses and permissions when dealing with bulk drugs, new drugs, test licenses etc.,
  • Food wherein support is given to the food business operators to successfully deal with FSSAI with regards to import assistance, FSSAI compliance, registration and licensing, product approval etc.,
  • Food wherein grantprocesses for manufacturing license, registration of food products, their testing, packaging and labelling etc., are all hastened up with the help of these regulatory partners,
  • Diagnostic kits which require various licenses for both notified diagnostic kits and those that are non-notified are required along with performance evaluation, support for meeting the MDAC etc.,
  • Narcotics which deal with quite a few stringent rules and requirements especially for obtaining manufacturing and import license for Psychotropic drugs and narcotics, NOCs for export and imports etc.,
  • Phytopharmaceutical drugs wherein assistance is required for its import, manufacture and also for conducting clinical trials,
  • Insecticides and pesticides wherein assistance is required for the registration of all pesticides, insecticides and herbicides, technical support and formulation, RTT import assistance etc.,
  • Medical devices and equipments which require Medical Device Registration in India, CDSCO clarifications, import licenses, performance evaluation etc.

The work of these regulatory partners thus starts from the time a concept is first formed and has to face the whole gamut of tough regulations till the time this concept is approved, licensed and registered. In addition to this, they also have to deal with any clash or friction that may arise between their client and the rules and regulations of the Government. In fact they have to act the perfect liaison between these industries and the Government to ensure the fulfilment of the needs of both.

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