Shantha Bio gets nod to launch 'Shankinase'

Company targets 10% of Rs 40cr-market in first year

City-based Shantha Biotechnics Private Limited has at last obtained the permission from Genetic Engineering Approval Committee (GEAC) to commercially manufacture and launch Shankinase.

Shankinase is the first indigenous recombinant streptokinase drug conforming to the international standards.

The drug is used to dissolve blood clots and also used as a life-saving drug in case of acute heart attacks and other conditions like deep vein thrombosis, arterial occlusions and pulmonary embolism.

Confirming the development to Business Standard, Shantha Biotechnics managing director K I Varaprasad Reddy said that the company received the GEAC permission on June 11, exactly 11 months after the company had approached it for commercial launch of the drug.

The company is gearing up to launch Shankinase in the next couple of months at less than half the cost of imported drug. The imported drug costs around Rs 2,400. The company estimates the market size for the drug at around Rs 40 crore and is targeting a 10 per cent market share in the first year.

Reddy regretted that precious lead time had been lost and much disrepute had been caused to the company following GEAC action on baseless allegations by an NGO based in Bangalore. Lack of clarity in the roles of DCGI and GEAC also led to the delay, he opined.

Reddy recalled that the Drug Controller General of India (DCGI) had approved of Shankinase last year after examining the clinical efficacy and all related parameters.

GEAC, when approached for permission to the launch of the drug, had raised an objection stating that the company had not sought its permission for clinical trials.

The company's explanation that GEAC was only required to accord approval for commercial manufacture of a product did not weigh with GEAC.

GEAC even sought a probe against the company based on the allegations about uninsured deaths during the clinical trials of the drug. The company gave an explanation that the drug underwent trials in five cities in the country.

Around 150 volunteers took part in the trials which were examined by the National Institute of Biological Standards and Controls, London.

The drug was used on 96 patients and three of them died as against the allegations of eight deaths, while all those who were administered the drug were insured.

The whole issue has caused much consternation among the nascent biotechnology industry in the country and the Association of Biotechnology-led Enterprises (ABLE) had also backed Shantha's contention.