Stepping up efforts to check illegal manufacturing and import of oxytocin in the country, the Central Drugs Standard Control Organisation (CDSCO) along with Bihar drugs control administration has raided 35 manufacturing units at Gaya and Bodh Gaya in the state and seized oxytocin injections worth Rs. 95 lakh from two units.
The raids were conducted by two teams comprising seven officials from CDSCO along with state drugs control officers under the guidance of Sudhir Kumar, joint secretary, Union ministry of health and family welfare and Dr S Eswara Reddy, Drugs Controller General of India.
During the raids, no oxytocin stock was found at 33 manufacturing units. Despite licence, the firms had not started manufacturing the drug. While two units- Nelko Chemical Works, Rangbahadur Road, Gaya and Anand Pharmaceuticals, Manpur, Gaya were found manufacturing oxytocin injections illegally. Their stocks were seized.
The manufacturing licence of Nelko Chemical had expired on August 23, 2017 and the firm did not renew it. 3,35,500 ampoules of oxytocin worth Rs. 57 lakh in the market were seized from the drug company. The ampoules were being manufactured without blister pack with an intention to divert the stocks for veterinary use. The firm failed to disclose the source of supply of the oxytocin bulk. It seemed that oxytocin bulk was smuggled from China through illegal channels.
An FIR has been lodged against Shyam Prasad Gupta and Ashok Kumar Gupta, directors of Nelko Chemical. The accused are absconding. The accused are repeat offenders under the provisions of the Drugs and Cosmetics Act. An FIR was lodged against them in 2015 for the same offence.
Another seizure was made at Anand Pharmaceuticals. 225200 ampoules of oxytocin worth Rs. 38 lakh were seized from the drug firm as it was found manufacturing oxytocin injections without blister pack with an intention to divert the stocks for veterinary use. The manufacturing licence of the company expired on December 31, 2016 and since then it was not renewed.
The firm had also not disclosed the source of supply of the oxytocin bulk. As per the available information, the oxytocin bulk appears to have been smuggled from China through illegal channels. An FIR has been lodged against Manni Lal Gupta, proprietor of the firm.
Altogether 35 manufacturing units raided in Bihar were found unfit for manufacturing parenteral (injectable) preparations. The products manufactured by them are a hazard for humans and animals. The manufacturers did not have laboratories for testing API/finished products.
In all the aforesaid cases, further investigation is underway.
Earlier, principal secretary to Prime Minister had requested DCGI to step up vigilance mechanism to check smuggling of oxytocin, in any form. Awareness campaign is also being undertaken highlighting the adverse effects of misuse of oxytocin formulations and the punishments for illegal production, distribution or use. NITI Aayog in a meeting held in April had also appealed to DCGI to conduct special operations to prevent and detect illegal manufacturing of oxytocin with the cooperation of the police wherever required. Further raids on manufacturers will be conducted regularly to curb illegal manufacture and distribution or sale of oxytocin.
Oxytocin is a peptide hormone approved for the use in human and animal for stretching the cervix and uterus to facilitate child birth. However it is being widely misused to milch cattle resulting in deleterious in both cattle and human.
In order to curb the misuse of oxytocin to milch animals, Union ministry of health and family welfare has undertaken various steps. The ministry made it compulsory for drug firms in 2001 to pack oxytocin in single unit blister packs only. In 2012, sale of oxytocin bulk was limited from a bulk manufacturer to a formulation manufacturer only without involving traders.
The ministry has stopped manufacturing of oxytocin injection by drug companies in the country from July 1, 2018. Only Karnataka Antibiotics and Pharmaceutical Ltd (KAPL), a government undertaking, has been allowed to manufacture oxytocin for domestic use. It has already banned import of oxytocin and its formulations.
However the ministry has postponed its decision to restrict the manufacture and supply of oxytocin to KAPL by two months following complaints from various states. With this, all the existing manufacturers can produce oxytocin injection for domestic market by September this year.