
New Delhi: The Centre on Friday proposed tighter scrutiny on sales of a life-saving drug called oxytocin, stirring hopes among doctors that the government will ease restrictions it had imposed earlier that they say could increase maternal deaths during childbirth.
The Union health ministry, in an August 10 notification, has proposed that oxytocin should be reclassified from the list of Schedule H drugs as a Schedule H1 drug that would require retail chemists to document each sale with greater scrutiny.
Chemists are expected to log sales of Schedule H1 drugs in a separate register, documenting the name and address of the prescriber, the patient and the quantity of the drug, and preserve records for three years.
The oxytocin notification - open for public response for seven days - comes amid opposition from doctors to restrictions from September 1 that ban oxytocin sales from retail chemists and require all hospitals and clinics to procure the drug directly from a single company. The curbs on sales emerged from concerns that oxytocin is widely abused in the animal husbandry to enhance lactation and milk yields from livestock.
Doctors are interpreting the proposal to reclassify oxytocin as a Schedule H1 drug as a step towards continuing its sales through retail chemists although the health ministry had earlier directed a ban on such sales from September 1.
"We're now trying to understand the objective of this H1 notification - we'll welcome continued availability of oxytocin through pharmacies," said Jaideep Malhotra, a gynaecologist in Agra and president of the Federation of Obstetrics and Gynaecologists Society of India.
The Indian Medical Association and FOGSI had earlier this week asked the health ministry to review its restrictions under which a single company - the public-sector Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) - will supply oxytocin across India.
Many doctors suspect the health ministry's decision to restrict sales of oxytocin emerged from either misinformation or pressure.
"Someone in government appears to have misinformed someone else within the government - otherwise, there's nothing to explain such a drastic step that could endanger women's lives," said Kankokkaran Vadakkeveetil Babu, an ophthalmologist in Kerala and member of an IMA panel on oxytocin that has decried the restrictions.
Two senior health ministry officials declined to discuss with this newspaper the circumstances or the sequence of events leading to the ministry's decision to impose the restrictions on oxytocin. "Our goal is to ensure that the medicine is available wherever and whenever it is needed," one official said.
KAPL has asserted that it has the capacity to produce and distribute all the oxytocin that would be required in the domestic market.
But doctors are still apprehensive whether KAPL has a robust enough distribution network to supply oxytocin - which needs to be refrigerated from point of production to point of use - wherever it is needed in the country.
"Anyone concerned about maternal health will understand the implications of the restrictions that the government had proposed and how they will jeopardise women's lives," said Mira Shiva, a public health physician.
Obstetricians say oxytocin is often administered as a prophylactic ahead of delivery to hasten contractions of the uterus and reduce the risk of bleeding. Doctors who have met health officials say the circumstances and motivations for the restrictions remain unclear. "Why was this decision taken? We're asking this exact question," Malhotra said.