Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

[op-ed snap] Questioning a crackdown

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Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Oxytocin, Drugs Technical Advisory Board (DTAB), Drugs Consultative Committee (DCC), Drugs & Cosmetics Act, 1940,  Indian Council of Medical Research, National Dairy Research Institute

Mains level: Laws regulating pharma sector in India & their occasional usage in an adverse way leading to more problems than solutions


Context

Recent ban on Oxytocin

  1. The decision of the Ministry of Health to restrict, from September 1, the manufacture of oxytocin only to the public sector unit, Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL), has sparked fears of shortages and a disruption of supplies of this drug
  2. The restriction is because of alleged misuse of the drug by dairy farmers on milch cattle to stimulate milk production
  3. The Ministry now hopes to control distribution channels and prevent misuse

About Oxytocin

  1. Oxytocin is a hormone that acts on organs in the body (including the breast and uterus) and as a chemical messenger in the brain, controlling key aspects of the reproductive system, including childbirth and lactation, and aspects of human behaviour
  2. Oxytocin is important during childbirth and breastfeeding
  3. Oxytocin is a neurotransmitter and a hormone that is produced in the hypothalamus
  4. From there, it is transported to and secreted by the pituitary gland, at the base of the brain

Is oxytocin really harmful?

  1. Minutes of the meetings of the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) — (statutory bodies under the Drugs & Cosmetics Act, 1940 cite experts from the medical and veterinary sciences who advised the DTAB that oxytocin is required in the treatment of both humans and animals
  2. Two studies by the Central government, by the Indian Council of Medical Research and the National Dairy Research Institute, conclude that the use of oxytocin does not have an adverse effect on either people or animals
  3. With cattle, the danger of misuse is that it may cause addiction, in which case cattle do not react to normal milk ejection stimuli

Why was production restricted to public sector company?

  1. It is due to a judgment by the High Court of Himachal Pradesh in a public interest litigation (PIL) initiated by the court after it came across newspaper reports of oxytocin misuse
  2. The court passed a judgment in 2016 blaming oxytocin for a number of diseases, including breast and uterine cancers, male impotence, excessive hair growth in women and balding for men
  3. However, the court did not cite a single scientific study to support these claims
  4. Towards the end of its judgment, the court directed the State government to consider the feasibility of restricting manufacture to the public sector
  5. The Central government decided to adopt the judgment as the basis of its order restricting manufacture to the public sector
  6. The fact is that the High Court sought a study of the feasibility of restricting manufacture to the public sector; it never ordered the restriction to be imposed

What should be the basis of the ban?

  1. A study of the degree of misuse
  2. The demand for the drug
  3. The manner in which the proposed restriction will affect the supply of the drug
  4. It’s impact on public health

Way Forward

  1. The regulation of drugs has to be rigorous and reasoned
  2. It appears that the government has gone ahead to restrict manufacture without conducting any kind of feasibility study
  3. The case for restricting the manufacture of oxytocin is neither rigorous nor reasoned
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