DRUG QUALITY IN INDIA

Central Drugs Standard Control Organisation (CDSCO) directed manufacturers of 49 medicines to recall their products after samples were found to be “not of standard quality”.

• Every month, drug samples are picked from sales/distribution points, analyzed and a list of Spurious Drugs and Not of Standard Quality (NSQ) Drugs are displayed on CDSCO portal.

Regulation of drugs in India

• CDSCO: Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, is the primary regulatory body for the pharmaceutical sector.
• It regulates quality,safety and efficacy of Drugs, Medical Device and Cosmetics in the country under the provisions of Drugs Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
• Drugs and Cosmetics Act (DCA), 1940: It along with Drugs and Cosmetics Rules, 1945, regulates import,manufacturing, sale and distribution of drugs in India.
  • Regulatory control is exercised through a system of licensing and inspection by the State Licensing Authorities.
• State Drug Regulatory Authorities (SDRAs): Responsible for licensing of manufacturing establishments, surveillance over sale of spurious drugs, instituting legal prosecution and monitoring of objectionable advertisements.
• Statutory Bodies: DCA 1940 provides for establishment of:
  • Drugs Technical Advisory Board (DTAB): Guides and advises central government on technical issues arising out of implementation of regulation.
  • Drugs Consultative Committee (DCC): An advisory committee to advise central government, state governments and DTAB on any matter tending to secure uniformity in administration of DCA.
• Central Drugs Laboratory (CDL): National statutory laboratory for quality control of Drug and Cosmetics.

Poor Quality Drugs Classification (Drugs and Cosmetics Act 1940) 

• Not of Standard Quality (NSQ) Drugs: Fail to meet the quality standards or specifications defined in Act.

• Spurious Drugs : 
• 

1. 1. 1. Imported under another drug’s name.
      2. Imitation/substitute for another drug, hiding true identity.
      3. Bears name of fictitious or non-existing manufacturer.
      4. Substituted by another drug or substance.
      5. Purports to be the product of a manufacturer of whom it is not truly a product.

• Misbranded Drugs
• 

1. 1. 1. So coloured, coated, powdered or polished that damage is concealed or made to appear of greater therapeutic value than it really is.
      2. Not labelled in the prescribed manner.
      3. Label makes any false or misleading claims for the drug.

• Adulterated Drugs
• 

1. 1. Consists of any filthy, putrid or decomposed substance.
   2. Prepared, packed or stored under insanitary conditions.
   3. Container is composed of any poisonous or deleterious substance.
   4. Bears a colour other than prescribed one.
   5. Contains any harmful or toxic substance.
   6. Mixed with any substance to reduce its quality or strength.