Just a few days after banning the import of oxytocin, a neurotransmitter and peptide hormone, the Central government has proposed an amendment to the Drugs and Cosmetics Rules to introduce a stringent barcode system for curbing widespread misuse of the drug in the dairy and horticulture industry. The move would ensure that oxytocin formulations manufactured and sold in the country remain easily traceable.

The Central Drugs Standard Control Organisation (CDSCO) has been pondering over rigorous measures to check the misuse of the hormone which has many beneficial therapeutic uses. 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 plan has left the domestic manufacturers fuming and various industry associations have made representations to the government against it. The latest step by the health ministry is expected to pacify domestic drug makers who have been batting for checks and balances to tighten the drug supply chain.

According to the proposed amendment to the D&C Rules, under Rule 96, a new clause instructing all oxytocin manufacturers to print necessary information to facilitate product trackability would be inserted. At primary packaging level, a two-dimensional barcode encoding unique and universal global product identification in the 14-digit Global Trade Item Number format along with batch number, expiry date and serial number of the pack should be printed. At secondary and tertiary packaging levels, a barcode encoding global product identification in the 14-digit Global Trade Item Number format along with batch number, expiry date and serial number of the pack should be displayed.

“Once the amendment materialises, all oxytocin manufacturers should have to maintain data on packaging and the product’s movement in the supply chain. The firm should upload the details on the central portal of the government or its designated agency before its release for sale or distribution. Ensuring timely upload of data on the portal will be the responsibility of the manufacturer,” an official source said.

Oxytocin causes uterine contractions thereby inducing labour naturally and controls post-delivery bleeding. But 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. Numerous studies have shown that its misuse causes hormonal imbalances in humans and shortens the lives of milch animals.

The proposed barcode system will go a long way in ensuring the tracability of the drug as many cases are being reported across the country of its illegal stocking and supply. “Having control over its manufacturing and sale is the only way to make sure that the drug is used for its intended purpose, that is, in the labour rooms for deliveries,” a healthcare professional opined.

The draft amendment also specifies packaging details of oxytocin formulations. Primary packaging level means the package which is in physical contact with the drug, secondary packaging level means the carton containing multiple primary packs including a mono carton and tertiary packaging level means a shipper containing multiple secondary packs.

“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 Drug Technical Advisory Board recommendations are implemented,” Federation of Pharma Entrepreneurs (Fope) President BR Sikri pointed out.

In fact, Fope had written a letter to the ministry of health to put forth the viewpoint of the industry and proposed suggestions to stop its misuse. In the letter, the federation categorically opposed the move to stop production in the private sector and pitched for tougher regulations to tighten the supply chain.