Very Good initiative for GMP Compliance.IF highest critical observation cancellation or suspension of Licence will be happened and stringent regulatory actions will be taken.
NEW DELHI: Drug makers had better watch out. Stung by US and European regulators finding fault with Indian plants, the Central Drugs Standard Control Organization (CDSCO) will soon start surprise checks at manufacturing sites. The move, along the lines of the inspection process of the US Food and Drug Administration (FDA), is part of an exercise to ensure the local market isn't flooded with substandard medicines, a health ministry official said.
The move comes amid growing concern about the quality of medicines made in India and demands for a tighter inspection mechanism by regulatory agencies. The inspections by India's drug regulatory agency could begin in a month's time, said the official, who spoke to ET on condition of anonymity.
An aggressive surveillance and enforcement system will help the government's drive to weed out drug units that may deviate from standard manufacturing practices thus compromising patient safety. Schedule M of India's Drugs and Cosmetic Rules 1945 lists the requirements for good manufacturing practices (GMP) certification and the Certificate of Pharmaceutical Products as per WHO guidelines.
Those deviating from quality standards face punishment.
"We may even issue suspension or cancellation of licences. In cases of major deviations, we may also (take legal action) against the company," said the official.
Indian regulators haven't been as harsh as the FDA and other international agencies against local manufacturing facilities.
"It is not a secret that some Indian companies follow two sets of standards--one for local-level consumption or supplies to markets that have a lower bar for regulatory acceptance and the other for developed markets like the US and EU," said an international GMP consultant.
A Drug Consultative Committee had in 2014 outlined focus areas for inspections such as establishing shelf life, conducting validation studies and ensuring prompt and effective recall besides the WHO GMP requirements.
"In cases of critical observations which have a direct impact on the quality, safety and efficacy of the products and where regulatory actions has to be initiated immediately, reports are to be finalized at the end of the inspection, without delay," the committee had noted.
The surprise audits will be carried out by 15-20 teams of three across the country, said the official cited above, adding that inspectors have already been trained for the purpose. At least 20-30 sites will be targeted for inspection in the first phase, the official said.
CDSCO is also looking to strengthen its workforce to ensure frequent audits and wide coverage. The regulator aims to employ 1,000 people in various cadres at the Centre and state levels over the next three years. About 250 of them will be for the inspection wing.
Quality-related lapses are among the main threats to the Indian pharmaceutical industry. In 2015 alone, the FDA issued close to 20 warning letters to Indian firms, the highest number of facilities flagged by the regulator here in a single year, according to a January ICRA Ltd report.
Sun Pharma, Cadila Healthcare and Dr Reddy's are among those that were served with adverse findings in the form of FDA warning letters for their manufacturing sites in the country last year. The issues of deviations included manufacturing conditions as well as tampering of data related to products meant to be shipped to US.
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