Alert highlights that sample of more than 50 drugs, including paracetamol, Pan D, calcium, vitamin D3 supplements etc. are “not of standard quality”.

• It also highlighted failure of several states in submitting data on quality of drugs . 

Drug Regulation in India

• Drug regulation is based on centrally-enacted Drugs and Cosmetics Act, 1940 (DC Act) and the corresponding Drugs and Cosmetics Rules, 1945 (DC Rules).
  • CDSCO, headed by the Drugs Controller General of India (DCGI) is entrusted with constant monitoring of drugs. 
    • It releases a Not of Standard Quality (NSQ) list monthly for assessing the quality and safety of drugs. 
• National Pharmaceutical Pricing Authority (NPPA) fixes/ revises the prices of controlled bulk drugs and also monitors the availability of drugs, identifies shortages, if any, and takes remedial steps.
• Since public health is a state subject, state governments also undertake drug regulation through State Drug Regulating Agencies (SDRAs). 

Issues of Drug Regulation in India

• Uneven Implementation: Number of Fixed Dose Combinations banned by DCGI are licensed for manufacturing under the State units. 
• Discretion of Officers in regulation:  DC Act or Rules do not provide any metrics to guide the regulation of drugs.
• Lack of trained and adequate personnel: Identified by Mashelkar Committee (2003). 
• Other Issues: Lack of coordination between SDRAs and center, lack of suitable infrastructure, funding, etc.