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Commerce ministry plans to add booster dose to border scrutiny to check spurious drug exports.


Date: 04-12-2009
Subject: Commerce ministry plans to add booster dose to border scrutiny to check spurious drug exports
New Delhi: After the health ministry declared the domestic pharma market largely free of spurious and substandard drugs, the commerce ministry now wants to step up the vigil at the checkpoints to scrutinise pharma export consignments and assess the quantum of spurious drugs that could be leaving the country and ascertain whether such channels of spurious drugs exist. The commerce ministry is considering a proposal to approach and collaborate with the customs department in the finance ministry to tighten the exercise of checking pharma export consignments and gather detailed information on trademark violations.

“This we planned keeping in mind the interest of Indian pharma industry. In many international forums, India is being blamed for being one of the major sources of counterfeit drugs. This measure of self policing could be used as a way of scientifically assessing the magnitude of the problem and validate or invalidate the international claims based on the results of the exercise,” a source said.

However, the industry is offering stiff resistance to the idea on the pretext that the implementation of such an exercise would mean that India is officially acknowledging the accusations being made and is conducting a probe on the same. The domestic industry feels that such accusations are being hurled at Indian generic industry deliberately without substantive evidence by quarters with vested interests. Such allegations are meant to tarnish the image of Indian pharma industry which is growing in stature internationally and eating into the business of big pharma firms on account of its low cost but good quality offerings, feels the industry. Industry also feels that such steps would increase bureaucratic hurdles for pharma exporters of the country and elaborate checking could cause unnecessary delays by disturbing the schedule of pharma consignments, finally leading to losses.

“We wouldn’t encourage such an exercise at all. The entire issue has flared up because of the EU seizures. If the drugs in the consignment in question is not under patent in the destination country and the country of origin, why should the in transit country create such an unjustified furore? We have been doing business with the US for years now. Nobody is questioning us there. I feel moving the WTO is the right way ahead,” said Venkat Jasti, CEO, Suven Life Sciences Ltd and former chairman, Pharma Export Promotion Council.

When contacted, DG Shah, secretary general, Indian Pharmaceutical Alliance said such a step by the government would.New Delhi: amount to almost admitting that we are at fault. “We must ask for evidence behind any official claim that remotely suggest that India is a source of counterfeit drug. This exercise of government could also be misconstrued and interpreted in different ways which could prove detrimental to the industry,” Shah said.

Daara B Patel, secretary-general, Indian Drug Manufacturers Association said, “We have maintained all along that these allegations are actually concerted efforts played out by big pharmas to give Indian generics a bad name. They are confusing IPR issues with the definition of spurious drugs that, too, we believe with a malafide intention. Why should we decide our policy measures based on these allegations, especially when we have three valid scientific surveys, conducted by the likes of WHO, government itself to prove that the penetration of spurious drugs in the domestic market is extremely low”.

A nation-wide health ministry study revealed that spurious drugs constitute less than 0.05% of the domestic market. FE was the first to report that only 11 out of collected drug sample size of 24,136, of which around 12% were tested were found to be spurious. The quantum of substandard drugs were found to constitute only 0.001% of the domestic market. Patel added that no good businessman would export spurious drugs and mar his own future growth potential.

Source : Financial Express

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