[Answered] There are glaring deficiencies in drug regulation that need urgent addressing. Comment.

Demand of the question Introduction. Contextual introduction. Body. Discuss various loopholes in drug regulation in India. Conclusion. Way forward.

Drug regulation plays a pivotal role in any country as it is critical to protect public health by ensuring the safety, efficacy and quality of drugs. Unfortunately there are so many lacunae in Indian drug regulation, that endanger public health. The Central Drugs Standard Control Organisation regulates the pharmaceutical sector in the country. Last year, the Bureau of Pharma PSUs of India, which implements the Pradhan Mantri Janaushadhi Pariyojana, found 25 batches of drugs supplied to be substandard, reflecting wide gap in India’s drug regulation.

Issues in Indian drug regulation:

  1. Spurious and substandard drugs: The country has an inadequate regulatory framework and enforcement regime, reflected in occurrences such a production of spurious or low quality drugs. Last year, Indian drug manufacturers received at least 20 letters of warning from the US FDA over the quality of their products.
  2. Lack of safeguard mechanisms: Lack of adequate mechanisms to safeguard illiterate and vulnerable patients, prevent informed consent violations and ensure proper functioning of institutional ethics committees.
  3. Deficiency in CDSCO: A report commissioned by an Indian parliamentary committee found Central Drugs Standard Control Organisation (CDSCO) struggled with staffing shortages, infrastructure issues and its responsibilities to ensure public safety. Besides, the Central Drugs Standard Control Organisation does not have the capacity to enforce an actual ban.
  4. Inadequate drug inspectors: Central and state governments have inadequate numbers of drug inspectors and an overall lack of capacity that leaves them incapable of enforcing recalls and uneven punishing violators.
  5. Coordination: Poor communication between state and central drug regulatory bodies compounds the problem. The little-to-no information-sharing between the Centre and the states, and among the states, leads to information asymmetry.
  6. Poor law implementation: India has among the toughest legislation that allows for life imprisonment if a drug is found to be spurious. But there is weak enforcement of law, so the number of prosecutions against offenders was low. 
  7. Inadequate drug inspectors: There ought to be one drug inspector for every 50 manufacturing units and one per 200 distribution retailers, according to a formula set out by the Malshekar committee. The number of drug inspectors in most states is inadequate. For instance, there was half the number of recommended drug inspectors in Gujarat.
  8. No time limit: There is no time limit under which drug inspectors working under State Drug Regulation Authorities are expected to complete their inspections.
  9. Ineffective Drugs & Cosmetics Act, 1940: Once a drug or brand is found to be substandard, all remaining stocks have to be withdrawn as per provisions in the Drugs & Cosmetics Act, 1940. But it rarely has been effective since detection often takes place months after a drug is released in the market. By the time a notification is issued, most stocks have already been sold.
  10. Lack of record: In addition, neither the inspectors nor the SDRAs are required to maintain a record or repository of information about non-compliant, errant and offending drug manufacturers. The lack of records means that cases of non-compliance seldom lead to prosecutions. Lack of data also made it difficult to identify repeat offenders.

Way forward:

  1. Better coordination: There is need for greater coordination, accountability and transparency in functioning among different ministries concerned with drug regulation.
  2. Central Drugs Authority: In 2013, the Ministry of Health attempted to create a ‘Central Drugs Authority’ that would oversee drug manufacturing. However, the proposal was rejected in parliament. This authority is needed to be established with more powers than CDSCO.
  3. Manpower: Government should fill vacancies on priority basis. More number of drug inspectors should be recruited to strengthen India’s regulatory framework.
  4. Timely action: Government must ensure that proper implementation of laws and timely action against the culprits is being taken. For this, coordination and information sharing with states must be prioritised.
  5. Banning: Life-time banning of repeat offenders should be there. Further, the government must strengthen states’ regulatory mechanism and empower CDSCO with power to out rightly ban the offenders.

Various committees like Mashelkar Committee Report, Ranjit Roy Chaudhury Committee report etc. have recommended making CDSCO like a body with its own independent staffing and finance. Government must work in this direction. It is important that the government must strengthen India’s drug regulation and ensure that offenders are punished under the law.

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