Comply with WHO standards, Centre tells pharma companies
Aditi Tandon
New Delhi, August 2
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.
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.
About the certification
WHO GMP certification is a great assurance of quality control. Several countries import drugs made only by WHO GMP-certified pharma units. India is a major exporter of medicines to low and middle income countries.
A slew of recent global medical alerts issued by the WHO in respect of Indian cough syrups and products have shone the light back on the need to plug fatal loopholes.
“The move is meant to ensure India’s place as the pharmacy of the world,” Union Health Minister Mansukh Mandaviya said.
What is Schedule M
Prescribes details of requirements for units, their maintenance, personnel, manufacture processes, safety testing, storage and transport of material, written records and traceability
Of the 10,500 drug firms, 8,500 are MSMEs (micro, small and medium enterprises).
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 that don’t comply can lose licences and face hefty financial penalties,” Mandaviya said, adding that ongoing risk-based inspections of pharma firms across India reiterated the need for a relook at the current GMP regulations and quality management landscape.
Of the 209 firms shortlisted for risk-based inspections nationally, 162 have been covered so far with serious lapses noticed.
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.
Mandaviya said more quality control would be enforced once the proposed amendment to the 1940 drug law was tabled in Parliament.
