Source: Business Line
Concerns raised by health authorities and non-compliance with international standards have prompted this push, with large companies given a six-month deadline and smaller ones a 12-month timeframe to comply.
India has tightened rules to ensure mandatory compliance with good manufacturing practices – which looks at bringing in quality control on materials, machines, processes, personnel, and facilities – by pharma companies.
All pharma companies must follow the revised good manufacturing practices and comply with the rules over 6-12 months.
While for small companies or MSMEs, with a turnover of lower than Rs 250 crore, compliance and certification processes are to be completed over a 12-month-period; larger ones or those with a turnover greater than Rs 250 crore need to put in place these compliances over the next six months.