No cancer causing impurities found in BP drug Valsartan during initial approval process, says DCGI

V G Somani said, according to the information he had the impurities were not found during the initial approval process of the product (Valsartan). DCGI is expected to go online for product approvals and other procedures in the next two years, he added.

New Delhi: An investigation is on to ascertain whether Valsartan, a drug used to treat blood pressure and heart failure, has any impurities that may be carcinogenic, Drug Controller General of India (DCGI) said here on Thursday.

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-Nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA)."

"That (the carcinogenic impurities) was a batch-specific phenomena. We are looking at it and we are investigating it. And 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," DCGI, VG Somani told reporters on the sidelines of a meeting here.

He noted that the Central Drugs Standard Control Organisation(CDSCO), 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" organized 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.

In a statement in May this year, the US Food and Drug Administration had said it continued to probe the presence of impurities in Valsartan and another angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure.

"FDA has identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)in ARB active pharmaceutical ingredient (API) and finished drugs.

Medicines with confirmed levels of NDMA or NDEA exceeding the interim acceptable intake limits have been recalled because they pose an unacceptable safety risk to patients," it had said.

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.

"I am giving you a conservative timeline that within two years we will be able to achieve a completely 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.

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