Pharma MSME given 12 months to comply with quality control norms

Out of 10,500 pharmaceutical production units in India, just about 2,000 are compliant with the WHO Good Manufacturing Practice.

The Union Health Ministry has given another 12 months to over 8000 small and medium-scale pharmaceutical manufacturing units to implement a set of quality norms that are at par with the World Health Organisation standards.

Such norms known as Schedule-M were a part of the statute since 2001 but were never implemented strictly for the MSME sector. The norms were upgraded in 2018, but the draft remained at the draft stage for the last five years.

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Out of 10,500 pharmaceutical production units in India, just about 2,000 – mostly the big players and exporters – are compliant with the WHO Good Manufacturing Practice – a set of quality norms for industrial production.

“The MSME sector largely is not WHO GMP or Schedule-M compliant. The rules have not been implemented forcefully,” Union Health Minister Mansukh Mandaviya said here on Wednesday.

Mandaviya said the companies with an annual turnover of more than Rs 250 crore would now have to become compliant within six months and those with a turnover of less than Rs 250 crore would get another six months to comply with such norms.

The decision comes at a time when the quality of Indian medicines is under scanner after multiple made-in-India cough-syrup triggered adverse health incidents reported in foreign countries, The WHO too flagged its concerns on the quality of such syrups.

The ministry said while inspecting 162 units and 14 public testing labs till now, the officials found major deficiencies like poor documentation, lack of process and analytical validations, absence of self-assessment and absence of quality failure investigation among others.

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Other shortcomings are the absence of internal product quality review, absence of testing of incoming raw material, infrastructural deficiency to avoid cross-contamination, absence of professionally qualified employees and faulty design of manufacturing and testing areas.

To plug such loops in the quality control system for pharmaceutical products, the ministry upgraded the quality parameters of Schedule-M in 2018 after a series of technical discussions with the stakeholders and issued a set of draft rules. But it was not finalised in the last five years.

“Considering the importance of upgraded and revised GMP to ensure quality of drugs, the government has decided to finalise the draft rules,” says the ministry in a statement, noting that the MSME would have to follow the 2018 norms.

Some of the major changes that will happen with the introduction of the revised Schedule M will be implementation of quality control norms like the pharmaceutical quality system and quality risk management system among others.

Other quality parameters that will be implemented are product quality review, qualification and validation of equipment, change control management, self-inspection and quality audit team, suppliers audit and approval, stability studies as per recommended climate condition and validation of GMP related computerized system.

Also there will be specific requirements for manufacturing of hazardous products, biological products, radio-pharmaceuticals and phyto-pharmaceuticals.

The ministry decided to go for a phased mechanism to comply with the quality norms in the wake of a meeting with the MSME players whose concerns were heard.

“This will address most of the deficiencies related to documentation and failure of investigation with the right type of technically qualified personnel doing the right job. Better quality management will help manufacturers grow their business nationally and internationally which is a huge opportunity for Indian pharmaceutical business," the ministry said.