Rule on life-saving drug worries docs

Doctors are worried over the Centre's decision to have hospitals and nursing homes across India procure a life-saving drug named oxytocin from a single public-sector company, fearing supply disruptions that could increase maternal mortality.

By G.S. Mudur
  • Published 23.07.18
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Picture: Shutterstock

New Delhi: Doctors are worried over the Centre's decision to have hospitals and nursing homes across India procure a life-saving drug named oxytocin from a single public-sector company, fearing supply disruptions that could increase maternal mortality.

The health ministry had earlier this year decided to ban oxytocin sales through retail chemists and direct the public-sector Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) to produce and distribute all the oxytocin within the domestic market.

The move followed longstanding complaints about the clandestine manufacture and abuse of the drug in the dairy sector to enhance milk production. The Centre's advisory panel on medicines had examined concerns that the unregulated use of oxytocin posed a risk to consumers and recommended the changes.

Oxytocin is a key drug that doctors use to prevent death from post-partum haemorrhage (PPH), or heavy blood loss during childbirth.

"Oxytocin is a life-saving drug for our mothers," the Federation of Obstetrics and Gynaecological Societies of India wrote to the drug regulators earlier this year.

"Any impediment (to) its easy availability for human use is likely to result in a significant rise in (the) loss of women's lives due to PPH."

The ministry directive requires hospitals and clinics across the country to procure oxytocin stocks only from KAPL. The date for this rule, initially set for July 1, has been revised to September 1.

But doctors have cited an email from a KAPL official that suggests the company began manufacturing the drug only from July 2 this year.

Jaideep Tank, secretary-general of the federation, said that KAPL had assured the medical community that it would be able to distribute the required oxytocin stocks across the country.

"As of now, we have no reason to disbelieve this assurance," Tank said. But many obstetricians say it's only when the company starts distributing the stocks that this assurance will be put to test.

"Within obstetrics circles, there are concerns about continued easy access to the product," said K.V. Babu, an ophthalmologist in Kerala who is worried that the nation's oxytocin stocks will hinge on one company.

Doctors estimate that India currently has more than 20 brands of oxytocin, and the obstetrics community typically relies on five or six brands of the drug.

Bhanumathi Prasanna Kumari, president of the Kerala Federation of Obstetrics and Gynaecology, said doctors were concerned whether a single company would be able to maintain the cold chain and supply of the drug to thousands of "delivery points".

"Every delivery point should have access to this medicine, which has been proven to be safe and effective in preventing maternal deaths," Kumari said. "We want the government to revoke this ban and make the drug available through more companies."