In a major development to permit production of the much discussed drug oxytocin, the Karnataka drugs control department has issued manufacturing license to the Bengaluru-based 34-year-old public sector undertaking Karnataka Antibiotics and Pharmaceuticals Limited (KAPL).
The move follows after the CDSCO in February end this year put forward stringent norms to curb import and distribution of Oxytocin, a powerful hormone that acts as a neurotransmitter in the brain which is used for human and veterinary use.
“The license dated April 6, 2018 is now granted to KAPL under Form 28 of the Drugs and Cosmetic Act & Rules. This will now enable the company to manufacture 5 IU (International Units) and 10 IU of oxytocin for domestic market consumption. We understand that the company has a production capacity to be able to commence manufacture of 1.5 lakh units to 2 lakh units per day,” Karnataka drugs controller Bhagoji T Khanapure told Pharmabiz.
Now KAPL will be the first company in the country to manufacture oxytocin after its facility was scrutinised by a joint inspection team of the state and central drug departments. Based on the recommendations provided by the deputy drugs controller of India sub-zone Bengaluru Dr. B Kumar, the license was issued. The manufacture and sale of oxytocin will be monitored by the enforcement wings across the country, he added.
Confirming the receipt of the license, KAPL managing director Nirja Saraf responded to a Pharmabiz email query that the company is fully geared up for manufacturing of oxytocin injection to meet the national requirement for the present as well as for future needs.
“As directed in the recently concluded meeting at the government level, KAPL is ready for manufacturing the injection oxytocin and is awaiting orders. After receiving orders the lead time for manufacturing and delivery of the oxytocin injection will be 60 days,” she added.
It is gathered that the company is now waiting for the blister packaging machine which is expected to be installed shortly. “We have already placed the order for the blister pack machinery, which is expected to be delivered at our Peenya plant, Bengaluru by the first week of July 2018 positively. Presently, we have the arrangement for blister packing, if the need arises,” stated Saraf.
KAPL is a leader among the pharma Central Public Sector Enterprises (CPSE). As per IMS, it is ranked 50th and is also having a WHO GMP certificate. We have a professional and qualified team to oversee the manufacturing and testing activity of oxytocin Injection, stated the KAPL managing director.