Aug 03, 2023 12:17 PM (IST)

Comply with WHO standards, Centre tells pharma companies

Units found wanting to face the music, says Mandaviya

After recent red flags over the quality of Indian medicines, the government on Wednesday instructed pharma
companies to become compliant with the World Health Organisation’s (WHO) good manufacturing practices
(GMP) that guarantee assured quality for domestic use and export purposes.

The minister said large manufacturers with an annual turnover of over Rs 250 crore had been given six months
to become WHO GMP compliant and those with a turnover of less than Rs 250 crore had been given 12
months for the transition. “Those who don’t comply can lose licences and face hefty financial penalties,”
Mandaviya said.

Major issues found during inspections

• Absence of testing of raw material (which may have led to recent instances of toxins in Indian cough syrups
linked to deaths in Gambia, Uzbekistan and Cameroon)
• Poor documentation
• Absence of internal product quality review
• Absence of investigation into quality failures; absence of means to avoid cross contamination
• Faulty design of units
• Lack of qualified professionals

Of the 10,500 pharmaceutical manufacturing units in India, only 2,000 (19 per cent) have WHO GMP
certification. The Health Ministry on Tuesday notified the pharma industry of the mandate to implement the GMP
under the revised Schedule M of the Drugs and Cosmetics Act, 1940, which was amended in 2018 to ensure
quality control but was never implemented on ground due to laxity of pharma units, which dithered on compliance.

Of these, 33 per cent (71) are in Himachal Pradesh followed by Uttarakhand (46), Madhya Pradesh (23), Gujarat
(16), Punjab (seven), Maharashtra, Tamil Nadu and Delhi five each; Haryana, Karnataka and Telangana four each;
West Bengal three; and Rajasthan, Sikkim, UP, Puducherry, Kerala, Andhra Pradesh, Bihar, Goa and J&K one
each.

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