The Hindu Business Line : `Accreditation of labs need of the hour'

THE importance of being quality conscious was underlined more than ever before, with the country's top regulators and the cream of the pharma world pointing out the need to accredit laboratories.

There is no system currently in place to make accreditation of laboratories mandatory and the little standardisation that is being done is not equipped to handle issues related to food quality or clinical trials, even as the country opens the flood-gates for drug trials, experts point out.

"Whether it is the pesticides issue (in the soft drinks controversy) or with clinical trials, the issue of quality has become of paramount importance. There is some accreditation being done by the National Accreditation Board for testing and calibration Laboratories (NABL), but there are several labs in the country that need to be accredited. The (Mashelkar) Committee on spurious drugs will not be making any recommendations on this. However, the Quality Council of India is said to be drawing up a vision statement that would also be addressing the issue," Dr R.A. Mashelkar, Director-General, Council of Scientific and Industrial Research (CSIR) told Business Line.

"NABL is doing some accreditation, but they do not have the expertise to do laboratories undertaking clinical trials," admitted Dr N.K. Ganguly, Director-General, Indian Council of Medical Research (ICMR), at a two-day conference on clinical trials organised by the Confederation of Indian Industry.

Meanwhile, the Drug Controller General of India (DCGI), Mr Ashwini Kumar, had on day one of the conference admitted that since there were shortcomings in infrastructure and expertise to give drug approvals and monitor clinical trials, the same could be out-sourced.

But in the recommendations made by the industry's working groups at the conclusion of the conference, it was pointed out that instead of out-sourcing it should build the expertise in-house and adopt the model of the Central Insecticide Board, for instance.

There was a unanimous cry for the need to harmonise regulations between the ministries of health, chemicals and fertiliser, science and technology and environment, the latter two coming into the picture in the case of bio-tech drugs.

A single-window clearance and automatic approvals for drugs approved in other markets to cut short delays in the domestic market were some of the other recommendations mooted by the industry.

Mr Rajiv Gulati, Managing Director, Eli Lilly, underlined the need to bring in discipline into the modus operandi of clinical trials and for this he suggested that "clinical trials as a subject be taught in medical schools to bring a discipline to the practise." The need for physicians to interact and exchange experiences was also important to evolve a regimen for the treatment of a disease based on experience, as seen in the case of cancer, he said.

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`Accreditation of labs need of the hour'