DTAB Current Affairs

Government bans imports of hormone oxytocin

The Union government has banned imports of hormone oxytocin to stop its misuse in livestock industry, where it causes hormonal imbalances and shortens the lives of milch animals. The Government has decided to rely on domestic production to satisfy requirements of hormone. It has asked customs officials to step up vigilance against those likely to try and smuggle oxytocin into India.

Background

India had halted retail sales of oxytocin as prescription-only drug in 2014, but failed to curb illegal sales and the volume of imports was unclear. Even, Drug Technical Advisory Board (DTAB) in February 2018 had recommended import ban of oxytocin. It also had recommended that sale be limited to registered government hospitals and clinics and bar code system should be used on all forms of drug to ensure tracking and prevent abuse. For adopting its recommendations, DTAB proposal had proposed amendments to section 10 of Drugs and Cosmetics Act, 1940 and rule 96 of Drugs and Cosmetics Rules, 1945.

Oxytocin

Oxytocin, often called love hormone, is released naturally in human bonding activities such as sex, childbirth and breastfeeding.  It is uterine stimulant hormone, prescribed for initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour. It is also used to help abort fetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. It may be used for breast engorgement.

Misuse

It is a controversial hormonal injection that is used widely in the dairy industry, agriculture and horticulture. The drug’s abuse in animals shortens their lives and makes them barren sooner. Even its misuse is reported among trafficked children, injected to accelerate puberty among girls. It is also being misused to speed up deliveries for pregnant women in overcrowded government hospitals.

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DTAB suggests one-time licensing for drugs

The Drugs Technical Advisory Board (DTAB) recently recommended one-time licensing for manufacture and sales of drugs.

If the recommendation is approved it will change present of the renewal of licences for each formulation which rests with state regulators and takes around three years. However, the new rule will have a condition that there be at least one annual inspection and in cases where risk is high.

Recommendations
  • Separate rules for manufacturing, import, sale and distribution of cosmetics. It has suggested the European Union’s model.
  • Making of influenza drugs Oseltamivir and Zanamavir must be made available widely at all pharmacies, by putting it in the Schedule H1 list.
  • These two drugs at present have been treated as Schedule X drugs and available at select pharmacies. Retain the four-year approval threshold for ‘new drugs’.
  • If the definition of a new drug is extended to 10 years, then innovation will take a back seat and wanting the four-year period to be retained.
Comment

If these recommendations are approved it will help in ‘ease of doing business’ and give fillip to domestic pharmaceutical sector under Union Government’s ‘Make in India’ initiative at a time when the country is slipping in the competitiveness index. It will also give a boost to pharmaceutical industry and give comfort to our customers.

Drugs Technical Advisory Board (DTAB): It is the highest statutory decision-making body under the Union Health ministry on technical matters. It is constituted as per the Drugs and Cosmetics Act, 1940.

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