The Central Drugs Standard Control Organisation (CDSCO) is in two minds over its move to restrict the manufacturing and distribution of oxytocin, a widely misused neurotransmitter and peptide hormone, to public sector enterprises. A top-level meeting of experts from the CDSCO and the Drug Technical Advisory Board (DTAB) held this week to look into the issue ended without making a concrete decision, it is learnt.
The country’s apex drug regulator, after a crucial meeting in February with manufacturers and industry lobby groups, mooted stringent regulations to check distribution of oxytocin, which was misused in the dairy and horticulture industry. A key proposal under consideration was restricting its manufacturing and distribution to public sector Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) and HLL Lifecare respectively. The move has left the domestic manufacturers jittery and various industry associations have made representations to the government against it.
“The officials discussed this issue from top to bottom. Most of them were of the opinion that one PSU manufacturer and distributor cannot supply a product, which has many beneficial therapeutic uses, all over the country. The meeting ended inconclusively,” a source aware of the development told Pharmabiz on condition of anonymity.
Oxytocin is included in the National List of Essential Medicines (NLEM) as a critical and life saving drug as it takes effect sooner than most other uterotonic drugs. A decision to push off private firms from its manufacturing will deal a severe blow to the domestic industry. There are more than 60 companies, spread across Maharashtra, Andhra Pradesh, Gujarat and Punjab, manufacturing oxytocin injections in India. Many of them will go out of business if the government plan materialises.
Often called the ‘love hormone’ as it is released when people snuggle up or bond socially, oxytocin causes uterine contractions thereby inducing labour naturally and controls post-delivery bleeding. It is misused in the dairy industry where livestock are injected with it to make them release milk at a convenient time. Many farmers use it to plump up vegetables. Studies have proved that its sustained use can cause hormonal imbalance in humans and ruin the reproductive system of animals, cutting their life span substantially.
The regulators are fully aware of this growing misuse. On April 6, the government banned the import of oxytocin and customs officials were asked to step up vigilance against those trying to smuggle it into the country, according to a notice issued by the Central Board of Excise and Customs.
“This import ban is not a solution to prevent misuse. They have to tighten supply network and weed out unscrupulous elements that use it for illicit purposes. We have informed the government many times that this wonder drug will be in short supply if the DTAB recommendations are implemented,” Federation of Pharma Entrepreneurs (Fope) president BR Sikri pointed out.
Industry associations have been pitching for checks and balances to tighten the drug supply chain. For instance, the CDSCO’s proposal for a bar-coding system for oxytocin formulations to ensure traceability is welcomed by the manufacturers.
“Banning production in the private sector will be a counter-productive measure for the domestic industry. Moreover, such policies would send the wrong message to investors and private drug makers. We will oppose them at all costs,” Fope co-chairman Vinod Kalani opined.