Substandard drugs


The CAG’s audit report of the Armed forces medical stores Depots(AFMSD), which serves our Armed Forces Personnel and their families, showed the percentage of locally procured substandard drugs at a high 32 per cent in one year
Reasons for substandard drugs in India?
  • European companies were selling medicines in India that had not been approved in their home countries, or in any developed country and failure of health ministry  to investigate the officials who granted such ‘illegal’ approvals.
  • Weak punishments:
    • No jail term
    • Small monetary fines
  • No coordination among states drug inspection units
  • No centralised drug licensing:
    • State government can cancel licenses
    • Two legislative efforts in 2007 and 2013 to centralise such regulations failed because of lobbying by the Indian pharmaceutical industry
    • There is no consolidated national list of manufacturers or total number of licenses granted, which makes it difficult to devise any concrete national or state policy for the regulation of this sector
  • In a tropical country like India, even high-quality medicines will become sub-standard if a chemist doesn’t take proper care. Inappropriate storage after the tablet leaves the factory caused the lack of uniformity of weight of the sample
What steps government took in this regard?
  • Amendment of Drug and Cosmetic act, 1940 in 2008 for making penal provisions and reset certain offences as perceptible and non bailable. When adulterated or spurious drug cause death then imprisonment imposed for not less than ten years or for lifetime
  • Jan Aushdhi’ generic drug stores in the Government hospitals and supply of generic medicine through Central Pharma Public Sector Undertaking
  • 14 states have created specially designated court under Drug and Cosmetic Act, 1940  For trial of offences related to adulterated and spurious drugs product
  • Enhancement of Central Drug Laboratories with new sophisticated testing equipment set up and creation of a new testing laboratory at Hyderabad
  • Banning Fixed Drug Combination (FDC)
  • Whistle blower Scheme – Under this scheme, if accurate information on the movement of spurious drugs product provided to the regulatory authorities, informers is suitably rewarded
What can be done?
  • Implementation of recommendations Ranjit Roy Choudary committee to have mandatory basic quality testing such as bioequivalence studies for all generic drugs
  • centralised licensing system should be created
  • India need to learn from American experience to take strong measures against repeted offenders



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