Health min gets tough on pharma sector
In a move to implement stringent regulations in the pharmaceutical industry, the health ministry has initiated a broad survey of generic drugs for quality test purposes. This includes testing of over 42,000 samples of different therapeutic drugs drawn from various manufacturers.“The survey is part of the quality assessment programme to increase the confidence levels for quality generic...
In a move to implement stringent regulations in the pharmaceutical industry, the health ministry has initiated a broad survey of generic drugs for quality test purposes. This includes testing of over 42,000 samples of different therapeutic drugs drawn from various manufacturers.
“The survey is part of the quality assessment programme to increase the confidence levels for quality generic drugs manufactured in India and is expected to be completed in the next six to eight months,” GN Singh, drugs controller general (India), the ministry of health and family welfare, said.
“We faced a lot of challenges in the last two years coming from various issues and competition in the manufacturing process of generic drugs. Hence, we decided to strengthen the regulatory system in India with strong quality control measures,” Singh said, who was here on Tuesday to attend a workshop at the US Pharmacopeial Convention (USP), a body which establishes network to advance quality medicines. USP aims to advance the sustainable development of official medicines control laboratories (OMCLs) that are capable of producing and sharing harmonised and internationally-recognised data, ensuring the quality of medicines, and combatting the proliferation of falsified and substandard drugs.
The survey is being done in association with the Indian Statistical Institute (ISI), Hyderabad and National Sample Survey Office (NSSO), Delhi. “The survey would help in identifying the geographical areas where spurious drugs are available so that a focused monitoring is done by the concerned authorities in these areas for eliminating the menace of spurious drugs,” he added.
The broad-based survey comes in the wake of recent development of increasing warning letters and alerts by the US Food and Drug Administration (USFDA) even while the US drug regulator is tightening its strings on Indian drug manufacturers. There are over 365 USFDA-approved plants in India, largest after the US.
He said that the exercise involves the process of drawing samples of medicines from public healthcare institutions and retail pharmacies to check their quality and efficacy. “We have also increased the number of drug inspectors from the 40 people in 2008 to 350 inspectors,” he said. “This will help bring in systematic inspections along with regular audits through a risk-based analysis of the drug samples,” Singh said. The ministry has also decided to make it mandatory to enforce good laboratory practices on the lines of good manufacturing practices.
“The survey is part of the quality assessment programme to increase the confidence levels for quality generic drugs manufactured in India and is expected to be completed in the next six to eight months,” GN Singh, drugs controller general (India), the ministry of health and family welfare, said.
“We faced a lot of challenges in the last two years coming from various issues and competition in the manufacturing process of generic drugs. Hence, we decided to strengthen the regulatory system in India with strong quality control measures,” Singh said, who was here on Tuesday to attend a workshop at the US Pharmacopeial Convention (USP), a body which establishes network to advance quality medicines. USP aims to advance the sustainable development of official medicines control laboratories (OMCLs) that are capable of producing and sharing harmonised and internationally-recognised data, ensuring the quality of medicines, and combatting the proliferation of falsified and substandard drugs.
The survey is being done in association with the Indian Statistical Institute (ISI), Hyderabad and National Sample Survey Office (NSSO), Delhi. “The survey would help in identifying the geographical areas where spurious drugs are available so that a focused monitoring is done by the concerned authorities in these areas for eliminating the menace of spurious drugs,” he added.
The broad-based survey comes in the wake of recent development of increasing warning letters and alerts by the US Food and Drug Administration (USFDA) even while the US drug regulator is tightening its strings on Indian drug manufacturers. There are over 365 USFDA-approved plants in India, largest after the US.
He said that the exercise involves the process of drawing samples of medicines from public healthcare institutions and retail pharmacies to check their quality and efficacy. “We have also increased the number of drug inspectors from the 40 people in 2008 to 350 inspectors,” he said. “This will help bring in systematic inspections along with regular audits through a risk-based analysis of the drug samples,” Singh said. The ministry has also decided to make it mandatory to enforce good laboratory practices on the lines of good manufacturing practices.
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