The Genetic Engineering Approval Committee (GEAC) under the aegis of the Ministry of Environment & Forests has taken Hyderabad based Shantha Biotechnics to task for launching recombinant streptokinase without seeking the mandatory clearance from GEAC. The committee in its meeting held here on November 27 took serious note of the unapproved clinical trials carried out by the company and subsequent deaths of some patients and asked Drugs Controller General of India (DCGI) to initiate a full fledged inquiry into the matter. The GEAC is to decide on the penal action to be taken against the company after going through the DCGI report.

The allegation of deaths during clinical trials was made by a local NGO. The organization had complained that eight people had died as a result of the drug trials. The NGO had also said that the company shifted its trial site from Hyderabad to Banglore in the wake of the reports of deaths.

However, it is yet to be clear whether the trials were conducted after proper sanctions from the DCGI. Under normal situations, DCGI clearances for recombinant products come only after GEAC gives a go ahead to the trials.

The GEAC directive is to have a negative impact on the market prospects of the drug. The company had launched its recombinant Streptokinase (shankinase), a lifesaver for acute myocardial infarction patients, in October. The high profile function had the presence of Dr RA Mashelkar, director general, CSIR and Dr Kodela Sivaprasada Rao, health minister of AP, among others.

The company had claimed that the safety and efficacy of Shankinase compared with commercially available natural Streptokinase in patients with acute myocardial infarction (AMI) i.e. heart attack have been proven in a multi-centric double blind randomized Phase III trial in prestigious hospitals.

"The drug's potency was tested by chromogenic assay method (a new testing method that will become part of European Pharmacopoeia and certified by a 3rd party international authority, National Institute of Biological Standards and Controls (NIBSC), UK. Launched after 3 years of intense R&D efforts and a investment of Rs. 10 crores, Shankinase aims to garner a 10 per cent share of this market in the year after launch ", they had stated. The market for Streptokinase in India is valued at over Rs. 65 crores currently and is poised to grow at 25-30 per cent.

Shantha Biotech is the second Indian company in India to launch the recombinant version of the drug. The first company to launch the product was Bharat Biotech International, another Hyderabad based company.

According to experts, a Cuban company introduced recombinant streptokinase in world market in 1994. Bharat Biotech was the second company in the world to launch the product and Shantha followed. Though natural streptokinase is included in all major pharmacopoeias, recombinant drug, being new, is yet to enter Indian Pharmacopoeia or British Pharmacopoeia.