Drug companies blast govt, say warnings ignored

BIRD FLU OUTBREAK

'The govt did not allow firms to go ahead with the processes to keep the drug ready'.

The drug industry has blamed the state and central governments for not attending to its bird flu alerts.

The pharmaceutical companies in India had in the last one year jointly and individually approached the governments to go ahead with the necessary processes to keep drugs ready for a health emergency.

"Since the high-risk virus has the potential for rapid infection and thereby creating a much serious health emergency, the industry and the scientific community had warned the government to keep enough stock of drugs and safety masks through imports as well as by allowing local manufacturers to carry out the necessary preparations. The authorities hardly paid any attention to it," says Dr Swati Piramal, director, Nicholas Piramal.

As a result, the country does not have enough stock of imported drugs and the local companies did get enough time to conduct bioequivalence tests for their generic versions to make the medicines available during an emergency, she added.

Dr Piramal had predicted the situation in a presentation at the Biotechnology Task Force meet in October in Mumbai last year.

Roche has the right to market Oseltamivir, the only 100 per cent efficacy proven bird flu drug. Since the company did not have the capacity to supply for world emergency requirement, it had proposed licensing of the product to a few generic companies in various markets, including India.

The Hyderabad-based Hetero Drugs was granted a licence by Roche to manufacture the drug after much negotiation under a complex arrangement by which the company did not transfer the original technology and market authorisation.

"This has further complicated the situation as the inventor company is not actually responsible for the quality of the drug manufactured by Hetero Drugs," said an industry analyst.

However, the bold step taken by Cipla to stockpile the drug much in advance has been appreciated by the medical fraternity. The company announced its plan to launch the drug in the domestic market and another 49 poor countries at a comparatively cheaper price a couple of weeks ago.

Dr Y K Hamied of Cipla said, "This is a lesson for the Indian authorities to learn how bad can be the impact of an unrealistic patent regime in a country like India."

The companies have informed that they would take at least two to eight weeks to make the formulation available in the market.

In case the disease spread across a single state like Maharashtra, it would need over 3.75 lakh doses in another two to three days, says an industry expert.

Srinivas Reddy, director, Hetero Drugs, is on record saying that it would require at least seven days to make the formulation from the current stock of API for one million capsules. The company reportedly has around two lakh capsules in its stock.

While Ranbaxy said it would be able to supply the drug only by the second half of the year, Nicholas Piramal, another company capable of making the drug, was yet to take a decision to manufacture the drug as it did not want to infringe Roche's patent.

In India, these drugs can be administered only when the patient show the symptoms for five days. It cannot be administered as a precautionary drug as the virus could develop a resistance.

Lab tests have confirmed that at least some of the chickens that died of bird flu in western India in recent weeks were infected with the deadly H5N1 strain, a state minister said here, announcing the country's first case of the disease.

Officials will immediately begin slaughtering hundreds of thousands of birds in a 3km radius around the poultry farms in the town of Navapur where the confirmed cases were detected, Anees Ahmed, the Maharashtra state minister for animal husbandry, said.

Tests on the birds were carried out by the High Security Animal Disease Laboratory in Bhopal.

Meanwhile, a scientist said an unknown number of people in the area near the outbreak were reported to be suffering from flu and fever, though there was no immediate indication they had contracted bird flu.

Milind Gore, the deputy director of the National Institute of Virology in Pune, which is approved by the World Health Organisation, said scientists there would begin testing samples on Sunday. At least 30,000 chickens have died in Navapur, a major poultry-farming region in Maharashtra state, over the past two weeks, Ahmed said.