Dr Ashok Kumar, president, R&D, Ipca Laboratories, also hailed the step. "This comes as a welcome step in the wake of rapid growth of the Indian biosimilars market, which has grown by a whopping 200 percent since 2008. These guidelines have come a long way from the abridged regulatory guidelines followed till now," he comments. Ipca Laboratories is a fully-integrated Indian pharmaceutical company with a biotechnology department involved in development of cost-effective processes for manufacturing of biologically- and fermentation-driven drugs and intermediates.

Issues before the industry

The guidelines have taken into consideration exceptions in the generally outlined product development pathway. "For example, the innovator product may have been developed in a particular host, but if the current expression systems are better in terms of quality of the product and yield, the guidelines have provisions for approval of products developed in a different host on a case-to-case basis. Similarly, approval of new formulation of an existing drug can be sought based on sound scientific data," points out Mr Subramaniam. "However, some areas such as critical indications (clinical trials involving infants) or where very long-term end points are measured could have been further clarified leading to faster approval of the drugs."

Dr Ella also raised concerns over some points in the draft. "It is too complex due to the involvement of multiple departments from different ministries. The Indian biotech industry requires a single window regulatory authority that is strict and transparent. The current system has companies applying to multiple regulatory authorities under different ministries to obtain permissions for biologic material import, product development, preclinical testing, clinical trials, marketing authorizations. A single window or single agency system is the norm in several countries with organizations such as the FDA in the US, EMA in European Union, ENVISA in Brazil and SFDA in China.

He suggests streamlining of regulatory processes for contract research organizations working for international clients on international products. Increased time-lines for receipt of biologic test articles from foreign locations would reduce competitiveness of the CRO industry, he says, while stressing on the need for a single agency system to further the cause of the biotech industry in India. Dr Ella says the Central Drugs Laboratory (CDL), Kolkata, has to take responsibility for the availability of authorized reference standards and their identities, which currently is under ambiguity. CDL Kolkata also could be developed along the lines of CDL, Kasauli, which receives batch samples for vaccines for testing and product release, he adds.