The Hindu Business Line : Final report on biotech cancer drug shortly

THE final call on the biotech cancer drug filgrastim is expected shortly, with the expert committee looking into the issue all set to submit its final report to the Drug Controller General of India (DCGI).

The biotech drug had shot into prominence when Nicholas Piramal India Ltd (NPIL) cried foul on a generic version of the drug, launched last year by Dr Reddy's Laboratories (DRL). NPIL imports and sells the drug, Neupogen, from the Roche-stable. DRL's version of the drug is called `Grastim'.

The three-member expert committee, headed by Dr N.K. Ganguly, Chairman of the Indian Council of Medical Research (ICMR), would take up the final report at its meeting later this week, ICMR top brass told Business Line. "Once the board clears the report, the two companies will be called for a subsequent meeting to give them an opportunity to respond to the final report," the official said.

The final report, which has taken close to a year to fructify, will be a water-shed of sorts as it would give direction to the country's policy on bio-generics. Chinese and Argentinean versions of filgrastim are already knocking at the doors of the DCGI and the matter has been referred to the expert committee.

According to the ICMR source, "There has been concern that generic versions in bio-technology is not similar to generic versions of any other drug. Bio-generics is a more serious issue and the International Committee on Harmonisation is yet to give a final call on the issue. Similarly, the committee may refer the bio-generics issue to the toxicity panel recently set up under the DCGI to look into recombinant drugs".

Meanwhile, filgrastim had seen a hi-decibel controversy with both companies making claims and counter-claims. In NPIL's presentation to the expert committee, earlier this month, Dr Swati Piramal, Chief Scientific Officer of the company, had pointed out: "The committee's decision is vital for India because it will determine whether untested biotech drugs will flood the Indian market without extensive clinical trials and sufficient clinical data before marketing these drugs".

Pharma industry sources point out that DRL had changed its product insert several times around and while this could pass in the case of a chemical drug, it may not be quite so simple with bio-tech drugs. "Is safety being compromised by allowing bio-generics into the Indian market? Are Indian laboratories equipped to test bio-generics? These are issues that the expert committee will have to address," the source said.

On its part, DRL had pointed out that all the fuss was because DRL's product was priced less than NPIL's drug. Recently, the controversy assumed a new hue with pharma industry representatives pointing out that one of the committee members was associated with a pharma company that was bringing in the Chinese version of filgrastim. "Commercial interests could cloud the final report," they observed.

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