In a major regulatory move, India has launched a multipronged strategy to enforce strict adherence to current GMP standards across the country’s massive manufacturing base.

Central Drugs Standard Control Organization (CDSCO), the federal regulatory agency, aims to update India’s two-tiered regulatory apparatus with the latest requirments, while ensuring the upgrade of manufacturing skill sets to deal with the changing quality requirements.

At one level, CDSCO has embarked on a process to streamline the activities of various state and central regulatory agencies. In India, state authorities govern manufacturing activities, and the adherence level to cGMP has been found widely varying in different regions.

As part of making a uniform and foolproof system workable for both agencies, CDSCO drew up a checklist describing procedures for auditing facilities and circulated the document among the state FDAs, with clear deadlines.

The checklist, along with the evaluation manua and providing a tool for self-assessment for their audit-readiness, will bring consistency in approach, especially on occasions where inspections are carried out jointly by the state and central agencies.

CDSCO has already started a training program for drug regulators and inspectors from state and central governments on various components of GMPs and GLPs listed in the document, including aspects of production, premises and equipment, hygiene, and written procedures.

Also, efforts are underway to bolster the regulatory mechanism. CDSCO has plans to add more than 500 new personnel and get them trained for the job. The agency would continue imparting training to officials in drug making factories across the country, according to G.N. Singh, Drugs Controller General of India (DCGI), who heads CDSCO.

The agency has been organizing training workshops in association with leading regulatory bodies including U.S. FDA for the inspectors involved in facility audit. Some of the state FDAs have already enlisted the services of professional agencies to equip themselves with the demanding aspects of inspection practices of different regulators.

The government decision to give an additional impetus to the ongoing efforts to fix the gaps in GMP compliance comes in light of findings that many factories continue to lag achieving the expected benchmark in production standards.

To address the skill deficits among the personnel working in manufacturing units, the government has commenced a compulsory certification program. It requires that all the persons employed in pharma and biomanufacturing need to obtain certificates after undergoing a course developed by the public-funded Life Sciences Skill Development Council (LSSSDC).

Through this first-of-its-kind initiative, CDSCO seeks to ensure that everyone engaged in the manufacturing job upgrade his skill sets. The government has set January 01, 2018 as the deadline to accomplish this goal. 

After this timeframe “no person shall be employed in any pharmaceutical/biopharmaceutical manufacturing unit unless he/she has obtained a formal diploma or degree in the relevant area, or has been certified by the LSSSDC or equivalent organisation in the area in which he/she has been deployed,” according to a notification published in the CDSCO website. 
The notification clearly states that the objective of the initiative is to bring substantial improvement in the quality of pharmaceutical products made in India.   

Seeking support from the industry, DCGI has requested all the pharma manufacturing units in the country take steps to ensure that persons employed by them are fully trained and certified.

Further, the authorities are looking at strengthening the existing rules governing GMP to expedite the whole process. Plans are afoot to revise the Schedule M of India’s Drugs & Cosmetics Rules 1945 to remove any hassle in the age-old laws that could impede the process of upgrading to the current WHO prescribed GMP levels. Schedule M is the section concerning manufacturing practices (GMP) in the rulebook.

Clearly, the government is going the extra mile to facilitate training the manufacturing workforce—a responsibility that solely lies with the drug-making firm. The certification of all manufacturing employees is unlikely to be a smooth ride within the stipulated timeline considering the enormity of the task. India’s highly diverse pharma manufacturing base comprises over 8000 small, medium and large players operating in API and formulation space.

The manufacturing sector, on the other hand, desperately needs a rapid makeover as it is facing unprecedented challenges when it comes to cGMP compliance. Also, the need to update skill sets becomes an urgency considering the highly competitive environment in the global marketplace. Responsive systems for manufacturing reliability and meeting regulatory compliance are a necessity for the promotion of India’s hugely promising contract manufacturing industry.