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No need to panic on USFDA observations: DGCI
A warning or a recall from the USFDA “does not mean that it will be followed by all other counties like Europe which also buy Indian drugs.
Hyderabad: A warning or a recall from the USFDA "does not mean that it will be followed by all other counties like Europe which also buy Indian drugs. Sometimes it only creates `panic'," says an expert.
Responding to the recall of Valsartan tablets (a drug used to treat blood pressure and heart failure) from the US market by some drug-makers after the US Regulator `found' some carcinogenic impact and an increasing number of warning letters to Indian drug makers from the FDA, V G Somani, Drug Controller General of India (DCGI), said "The US has the right to do whatever they want to do. We see it a customer as well as regulator and our job is to satisfy them fully on all counts."
"An investigation is on to ascertain whether Valsartan, has any impurities that may be carcinogenic. We will take appropriate decision on whether to accept it as a risk, whether to take some action on prescribing the product or whether to ban the product.
We have a subject expert committee, we have chemical experts, we go through all the things," the DGCI said here on Thursday on the sidelines of a meeting of regulators organised by Pharmaexcil.
The DCGI move comes after several lots of drugs containing Valsartan ingredient were recalled voluntarily by firms including Aurobindo Pharma and many other multinationals from the US market due to "presence of traces of impurity, N-Nitroso dimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA)."
Somani noted that Central Drugs Standard Control Organisation (CDSO), under the Ministry of Health and Family Welfare was carrying out the investigation.
He was in the city to take part in the inaugural session of "International Regulatory Convergence to Promote Accessibility and Affordability of Quality Medicines" organised by Pharmaceuticals Export Promotion Council (Pharmexcil).
Somani further said, according to the information he had, the impurities were not found during the initial approval process of the product (Valsartan).
However, they were noticed when the final product has come out. Somani said the DCGI is expected to go online for product approvals and other procedures in the next two years. According to him, some of the services would be available next year itself.
"I am giving you a conservative timeline that within two years we will be able to achieve complete transparent online system where the entire world can depend based on our website.
Product certification and its evolution everything will be available online for the entire world," he added.
Noting that India supplies 40 per cent of drugs to the world by volume currently, he said the same would be increased to 60 per cent in the next three years.
Somani termed shortage of human resources and laboratory infrastructure as a `challenge' going forward. DCGI is setting up a training academy for regulatory staff.
