R Ramakrishna, deputy drugs controller, told FE, We have carried out inspections at several sites in the region under instructions from the DCGI, but said he wasn't aware if these were initiated as a new measure to tighten controls. Annual inspections do happen at human trials sites, mostly as a continuing process of compliance, he added.
KV Subramaniam, president and CEO, Reliance Life Sciences said his company views these inspections positively as it helps bring about better standards in the clinical trials being conducted. The company operates state-of-the-art clinical trial facilities and all the clinical research studies conducted are in compliance with ICH-GCP guidelines and applicable Indian laws governing clinical research, he added. A mail sent to Glenmark was not answered till evening on Tuesday, while Wockhardt officials could not be contacted for comments. A mail sent to Glenmark was not answered, while Wockhardt officials could not be contacted for comments.
The checks, coming weeks after the DCGI, part of the Central Drugs Standard Control Organisation under the ministry of health, cancelled the license of a clinical research firm in Andhra Pradesh on grounds of irregularities in conduct of human trials, is seen as a move to tighten clinical research standards, and has put the industry on high alert. A recent controversy regarding trials involving poor women from Piduguralla town in Andhra Pradesh had kicked up a storm, with the women complaining of complications following a test allegedly conducted without their consent.
Last month, the DCGI cancelled the licence of Axis Clinicals after inspecting its facility in Hyderabad, preventing it from undertaking any BA/BE studies. Bioavailability is the relative amount of drug from a particular dosage which enters the circulation system, and the rate at which the drug appears in the systemic circulation. Bioequivalence of a drug is achieved if its extent and absorption are equal to those of the reference product when administered at the same dose.
According to estimates, till 2010, there were as many as 250 global trials of medicines going on in India, and around 200 local trials. However, there has been a slow down of the approval process since then.
There would be around 30 large clinical research organisations or CROs, but not all of them conduct BA/BE studies. Many of the large pharmaceutical companies have facilities that conduct their own BA/BE studies. Although steps have been initiated by the DCGI for proper audit of CROs and imposition of strict guidelines for ethical committees, issues continue to dog the industry owing to poor imlementation.
Subramaniam added, Reliance Life Sciences does believe there should be oversight by the regulatory authority, while, at the same time, it should not stifle growth of the industry.