The Navi Mumbai-based Accutest Research Laboratory has become first independent Indian laboratory to get the US FDA approvals with clearance for its bioequivalence project of ciprofloxacin hydrochloride 500 mg tablets.
The Project was submitted by Accutest as part of an abrreviated new drug applications (ANDA) submission for JB Chemicals and Pharmaceuticals. Similarly, it has also received other prestigious approvals, which include Drug Controller General (DCGI-INDIA), ANVISA (Brazil), Regulatory Body of Zimbabwe (MCAZ).
Confirming the approval, Dr Santosh Joshi, director, said that they were excited about the achievement and committed for sustained quality standards in future.
Accutest Research laboratory was estblished in 1998 in Navi Mumbai with well-equipped Clinical Pharmacology Unit and state-of-the-art Analytical Laboratory. Almost 40 scientists are working on different projects including physicians. The company has done ANDA for leading pharma companies including Cipla, Wockhardt, Zydus Cadila, Lupin and Glenmark.
As part of its recent expansion drive, the company has established one more separate bioequivalence centre in Pune, which is approved by DCGI. With the US FDA approval to Accutest, a number of large pharmaceutical houses nationally and internationally will have alternative choice to outsource their projects in INDIA which will give them definite advantage in terms of cost and time, Dr Joshi added.
Apart from bioavailability/ bioequivalence projects, Accutest has already begun its logical extension to existing business spectrum by entering into clinical trials activity.
The contract research organisation (CRO) industry is growing up and Accutest management feels that this comparatively nascent industry till 2002 had spent 10 per cent of annual R&D spending by sponsoring international drug companies and it is going to double by 2007. We believe that with Patent regime coming into force from 2005, scenario with Indian Pharma Industry is not going to be different, Dr Joshi said.
The concept of outsourcing some of the activities by pharma companies to CRO's though dates back a long way, has gained wider acceptance in changed circumstances with new technologies and delivering models. Few years back, focus of outsourcing was mainly due to cost factor. But today the scenario has changed. Outsourcing facilitates in bringing the products nearer to customers reduce the distribution costs. It also accelerates in dispersal of industries across the country, which helps in generating employment. It brings mutual benefit in long term for both outsourcer and out source.
Despite dire pipeline predictions for many large pharma companies, the CRO future appears rosy, due to improving relationship with sponsors, a commitment to expanding global services and learning to be flexible in an ever changing R&D Paradigm.
Earlier, relationship between sponsor and CRO was of master/slave type. For years, CRO's were at the whim of their sponsors. Trials were cancelled and projects were halted, leaving CROs to pick up the pieces.
Now our clients have come to realize that hiring someone as a vendor, treating them like a vendor, not sharing information, is very time consuming and very expensive. Changing different CRO they are not creating value to their company. A number of large pharmaceutical clients right now are saying lets pick one or two CROs and make them part of our team, Dr Joshi said.
Pharma companies will find it much easier to outsource to someone whom they know and trust over time rather than treating CROs like vendors whom they do not know or trust, he pointed out.