Pharmaceuticals & Health Care Sector

India is the largest provider of generic drugs in the world and supplies over 50% of global demand for vaccines. India is world’s third largest pharmaceuticals producer and has a network of 3,000 drug companies and over 10,000 production units. And as per India Economic Survey 2021 this sector will see a whooping three folds growth in the next decade and will reach to US$120-130 billion by 2030. But it comes with a lot of complex regulations and guidelines which need to be followed strictly under an expert supervision as any kind of violation in drug laws could result in serious consequences not only for the firm but also for general public.

Regulations and guidelines in which FASTRACK LEGAL SOLUTIONS can assist are: -

  1. CDSCO:  central drugs standard control organisation provides about general information about drug regulatory requirement in India
  2.  NPPA: national pharmaceuticals pricing authority is the governing body dealing with pricing
  3. D&C ACT,1940: drugs and cosmetic Act regulates the import and distribution of drugs 
  4. THE PHARMACY ACT,1948: it regulates the profession of pharmacy 
  5. THE NARCOTIC DRUG AND PSYCHOTROPIC SUBSTANCES ACT,1985
  6. WHO GUIDELINES: regarding medical policy, intellectual property rights, etc
  7. OECD: covers economic and social issues in areas of health care

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