The Union Ministry of Health and Welfare on Wednesday issued a deadline to drug manufacturers in India to adopt the World Health Organization’s good manufacturing practices which were revised in 2018, reported The Indian Express.
The World Health Organization’s good manufacturing practice system is aimed at ensuring that products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation”.
Health Minister Mansukh Mandaviya said that companies with a turnover of over Rs 250 crore will have to implement the revised guidelines within six months, while medium and small-scale enterprises with a turnover of less than Rs 250 crore will have to implement them within a year.
“Those who do not comply with the direction will face suspension of licence or penalty,” the minister said, according to The Indian Express.
He also added that out of the 10,500 manufacturing units in the country, only 2,000 were found to be following World Health Organization’s good manufacturing practices.
An unidentified official told The Indian Express that adaptation of the manufacturing practices will lead to at least 11 specific changes in the process, including the introduction of a pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
The decision by the government comes against the backdrop of deaths caused due to “contaminated” India-manufactured cough syrups and eye drops in several countries.
The World Health Organization and the United States’ Centers for Disease Control and Prevention had raised alerts about the quality of drugs manufactured in India.
The global health body sends out such alerts in rare cases when there is a significant threat to public health and a concern that the risk extends beyond a country.
Since January, three ophthalmic products made by Indian companies had been red-flagged for poor quality. These included products made by Indiana Opthalmics, Global Pharma, and Galentic Pharma.
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