Centre takes away state powers for issuing NOC for export of drugs

News Excerpt: 

The Union government has become the sole authority for issuing manufacturing licences for new drugs meant for exports, withdrawing the power from state governments amid heightened global scrutiny of Indian made drugs.

Background:

  • The move comes in the backdrop of multiple incidents where drugs and cough syrups manufactured in India have allegedly been found to be contaminated. 
  • Cough syrups imported by The Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG), resulting in cases of acute kidney injury among kids.
  • An investigation led by the United States Centers for Disease Control and Prevention (CDC) and Gambian scientists in March "strongly suggested" that medications contaminated with DEG or EG imported into the country led to the cases among children. 
  • A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%.

More about News: 

  • India's drug regulator has withdrawn powers delegated to the state licensing authorities to issue no objection certificates (NOC) for manufacture of unapproved, banned or new drugs for export purposes, a move that comes in the wake of substandard Indian drugs causing health concerns in several countries.
  • The sole licensing authority from now on will be the Central Drugs Standard Control Organisation (CDSCO). 
    • CDSCO is India's apex drug regulatory body.
  • It has been decided with the approval of the honourable Health and Family Welfare Minister that industry must be facilitated to file fresh applications for NOC for manufacture of unapproved/approved new drug/banned drugs solely for export purpose from 15 May 2024 on online mode through CDSCO zonal offices.
  • Manufacturers will need to obtain the NOC from the respective zonal office of the CDSCO through online mode (SUGAM).
  • All state/UT drugs Controllers are required to handover all NOC issued from 20 August 2018 to 14 May 2024 to respective Zonal offices of CDSCO. Conclusion

The CDSCO's latest decision comes in view of the Drug Consultative Committee's (DCC) advice who had found that the process of obtaining NOCs from various state drug regulators for pharmaceutical products is a time-consuming process. The DCC also pointed out that delays in obtaining NOCs could cause delays in the export consignment since applicants must obtain an export NOC and a manufacturing license from state licensing authorities for each purchase order.

The Drugs Consultative Committee.

  • The Central Government has the authority to establish an advisory committee named "the Drugs Consultative Committee" to offer guidance to the Central Government, State Governments, and the Drugs Technical Advisory Board on issues aimed at ensuring consistency in administering this Act.
  • This committee, comprising two representatives appointed by the Central Government and one representative chosen by each State Government, convenes at the discretion of the Central Government. 
  • It possesses the autonomy to govern its own proceedings.

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