Indian pharma companies are facing criticism for below-par manufacturing practices, which are impacting their brand and the larger Indian pharma industry. The government has ordered pharma companies, particularly MSMEs, to acquire Good Manufacturing Practices (GMP) certificates within the next 6 to 12 months. However, only 2,000 of the 10,500 manufacturers have a GMP certificate, highlighting the problem. Non-pharmacopeia grade solvents negatively affect drug quality, industry reputation, and India’s global brand image.
The government must also take a more proactive stance on the usage of Pharmacopoeia monographed solvents and excipients, such as IPA, Acetone, MDC, and Methanol, by Indian drug manufacturers in their preparation of APIs, final formulations, and pharma products. The government must lead a similar campaign against those turning a blind eye to solvent usage rules and regulations.
Vikas Biyani, an expert with state regulatory bodies, warns that not adhering to Good Manufacturing Practices (GMP) regulations can undermine a company’s brand image and corporate reputation. The government is collecting details on pharma companies’ plants, but should also lead a campaign against manufacturers who ignore solvent usage rules. The declining brand value of pharma companies due to spurious drugs is negatively impacting India’s exports.
