New Delhi: Domestic drug firms have come out strongly against a government proposal to regulate the controversial but life-saving growth drug oxytocin.

Companies manufacturing oxytocin say the availability of the drug will be severely hit if the government restricts its manufacture to only one company in its drive to curb the misuse of the drug by dairy owners and farmers, who use it to boost milk production and increase the size of vegetables.

The Central Drugs Standard Control Organization (CDSCO) proposes to regulate the supply of oxytocin injection to only one manufacturer, a move that would hit other domestic manufacturers.

With drug firms and pharma lobby groups raising their objections, the matter of how to ensure effective regulation and restriction on manufacturing and sales of oxytocin will now be taken up on Wednesday by the government’s think tank NITI Aayog, along with experts from the ministries of agriculture, health, science and technology, and the department of revenue.

Oxytocin is prescribed for the 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 the foetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. But it is controversial because it is used widely in the dairy industry, agriculture and horticulture. Authorities are also concerned that the misuse of this growth booster is reported among trafficked children, injected to accelerate puberty among girls. The minister for women and child development, Maneka Gandhi, has been pushing for a ban and had taken up the issue with health minister J.P. Nadda.

Consequently, as reported by Mint first, the government’s top drug advisory board—the Drug Technical Advisory Board (DTAB)—in a meeting on 12 February recommended various measures to check the drug’s misuse. Other than proposing curbs on imports, it also proposed the drug be manufactured by only one firm, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector unit, and be marketed by another, HLL Lifecare Ltd. “The other manufacturers will henceforth have to stop production," two people in the know said.

“Government is almost determined to restrict manufacturing and marketing of oxytocin by pushing off private companies. However, a lot of representations have been sent from both pharma companies and pharma lobby groups. Government’s think tank will take up the matter with experts from other ministries on Wednesday and we hope to get a breather," said the first of the persons cited above.

According to CDSCO, currently there are 80 licenced manufacturers including pharma major Pfizer and Novartis and there is only one manufacturer of oxytocin active pharmaceutical ingredient (API). Oxytocin is included as a lifesaving drug in the National List of Essential Medicines (NLEM) and hence according to pharma lobby group Indian Drug Manufacturers’ Association (IDMA), its regulation will lead to “shortages" and “widespread panic". In their representation to the CDSCO, the IDMA raised concerns over the illegal trade of oxytocin. “Oxytocin API is reportedly widely smuggled into the country, mainly from China and formulated by illegitimate and unlicensed formulators. Government must focus on curbing smuggling of oxytocin API," it said. Mint has reviewed the copy of the representation.

The drug cannot be banned for its beneficial medical use.

“Banning its import is not a solution. It requires strict regulation. It is an internationally established first line drug used for active management of third stage labour and there is no substitute," said B.R. Sikri, president of Federation of Pharmaceutical Entrepreneurs (FOPE).

A senior executive of a leading pharma company who did not wish to be named said the government’s policy of restricting the drug is a “matter of concern" for private drug makers and government needs to rethink their strategy.

“What do we do with the stock of API lying with us. Also it won’t be feasible for one manufacturer to fulfil the demand. The drug is under NLEM and costs about Rs15-16. It will be a costlier affair for any one company to market the drug effectively; the price cannot be justified. Why can’t government regulate this substance similar to psychotropic substance instead of completely pushing off private players?" he asked.

While Pfizer’s spokesperson said that they would be fully supportive of any measures that curtail ‘clandestine import’, ‘unlicensed manufacturing’ and ‘illegal sale’ . However, “As such, the availability of this medicine for prescribed human use, and the legitimate manufacturing & distribution of this medicine by pharmaceutical companies with valid licenses and in compliance with Government regulations should not be compromised. We will continue to provide our inputs into this decision making process."

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