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.
The rules were notified recently, thereby making such good manufacturing practices and adherence to Revised Schedule M mandatory for everyone.
Good manufacturing practices (GMP) are mandatory standards that build and bring quality into products by controlling materials, methods, machines, processes, personnel, and facility/environment.
According to a Union Health Ministry official, around 10,500 manufacturing units in the country, around 8,500 fall under the MSME category. Around 2,000 MSMEs, mainly exporters, have a WHO GMP certification.
India is a major exporter of medicines to low and middle-income countries which require this WHO GMP certification.
“The CDSCO (drug regulator in India) has inspected 254 manufacturing units and 112 public testing labs till now. Major issues found during inspections are poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material, infrastructural deficiency to avoid cross-contamination, absence of professionally qualified employees, faulty design of manufacturing and testing areas etc,” the official told businessline.
Based on the above findings and to keep pace with the fast-changing pharmaceutical manufacturing and quality domain, there was a necessity to revisit and revise the principles and concepts of good manufacturing practices.
Major changes post notification of rules will lead to the introduction of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), Qualification and Validation of equipment, Change control management, Self-inspection and quality audit team, Supplier audit and approval, among others.
“In order to have smooth transition from the present Schedule M to the revised Schedule M, it has been decided to provide a transition period 6 months and 12 months for large manufacturers ( greater than Rs 250 crore turnover) and MSME ( less than Rs 250 crore turnover),” the Central government notification reads.
According to Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, the revision of Schedule M will elevate the quality standards of medicines.
“Regulations of Schedule M will help ensure compliance with international quality standards and will benefit both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs. The focus on risk management, qualification and validation of equipment, and self-inspection will be vital contribution,” he said.