Indian pharma companies are facing challenges in manufacturing practices, which are affecting their brand and the reputation of the industry. The government has ordered pharma companies, particularly MSMEs, to acquire Good Manufacturing Practices (GMP) certificates within 6 to 12 months.
However, only 2,000 of the 10,500 manufacturers have a GMP certificate, highlighting the problem. The government must also take a proactive stance on the usage of Pharmacopoeia monographed solvents and excipients, such as IPA, Acetone, MDC, and Methanol, by Indian drug manufacturers.
The Indian Pharmacopoeia Commission mandates maintaining pharmacopeia standards, but Indian drug manufacturers often use non-pharmacopeia-grade solvents. This not only adversely impacts drug quality but also undermines the brand image of India as a ‘pharmacy of the world’. Expert Vikas Biyani suggests that the government should enforce standards mandated by the Indian Pharmacopoeia or International Pharmacopeia in pharma applications and bring suppliers to pharma manufacturers under the gambit of monitoring authorities.