As reports of widespread misuse of Oxytocin, a neurotransmitter and peptide hormone, in dairy and horticulture industry crop up on a daily basis, the Central Drugs Standard Control Organisation (CDSCO) has decided to make the regulations more stringent to tackle the menace. The top brass of the national pharmaceutical regulatory body will hold a crucial meeting on February 22 with all the manufacturers of Oxytocin formulation for human and animal use in the country to discuss ways to check the misuse of the drug which cannot be outrightly banned as it has many beneficial medical uses.

“The government is aware of illegal manufacture, import and sale of Oxytocin in the country. Various measures have been taken by the CDSCO and the ministry of health and family welfare to curb its misuse. But we need the support of the industry to bring these steps to a successful conclusion,” an official said.

Oxytocin, also known as ‘love hormone’ as it is released when people snuggle up or bond socially, has various medical uses. It causes uterine contractions thereby inducing labour naturally, controls post-delivery bleeding and helps new mothers lactate. However, it is misused widely in the dairy industry where livestock are injected with it to make them release milk at a convenient time. The hormone is also used by farmers to plump up vegetables such as pumpkins, watermelons, brinjals, gourds and cucumbers. Several studies have proved that sustained use of the drug can cause hormonal imbalance in humans and ruin the reproductive system of animals, cutting their life span substantially.

The CDSCO had stepped in several times in the past to control the misuse of Oxytocin.  It is classified as a Schedule H drug under the Drugs and Cosmetics Act, 1940, and can be sold on the prescription of a medical practitioner only. The injections are packed in single unit blister packs to avoid its bulk sale. Earlier this year, the regulator issued an Oxytocin alert asking drug controllers to crackdown on illegal use.

Despite these measures, cases of misuse surface frequently. Last month, more than 20,000 samples of veterinary Oxytocin were seized in Patna. But the drug regulator’s stern actions don’t go down well with the manufacturers in Bihar. The drug controlling authority is rapped for lack of transparency in regulations. The manufacturers point out that the use of veterinary Oxytocin in blister packaging is allowed in veterinary colleges and hospitals.

“It is not a banned drug. Its sale is restricted only in the retail market. Manufacturers will make drugs that are in demand. The implementation of regulations is the responsibility of authorities,” Bihar Drugs and Pharmaceutical Manufacturers Association president Sanjiv Rai told Pharmabiz.  

According to sources, the meeting on February 22 would weigh options such as a ban on import, tighter distribution norms and stricter rules to prevent its agricultural use. Representatives of Indian Drug Manufacturers Association (IDMA), The Organisation of Pharmaceutical Producers of India (OPPI), Federation of Pharma Entrepreneurs (FOPE), Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Federation of Animal Health Companies (INFAH) are expected to take part in the deliberations.