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Policy Matters

Govt may allow third-party audits for drug quality

Mumbai: Private audit firms specialized in pharmaceutical manufacturing practices and quality standards may be allowed to issue compliance certification to drug makers—a first in India—if the health ministry clears a proposal by the Planning Commission.

Third party audits in drug factories, a practice accepted in developed countries including the US, is likely to be allowed initially for traditional medicines and may then be extended to modern drugs, said Anil Jauhri, director, National Accreditation Board for Certification Bodies (NABCB), a unit under the Quality Council of India.

If implemented, this will resolve the long-pending issue of a manpower crunch in central and state drug regulatory agencies and will strengthen the quality audit system.

The proposal is under the consideration of the health ministry as part of new thrust areas for the healthcare sector.

The health division of the Planning Commission had recommended that the drugs inspection machinery, suffering from a paucity of resources, be supplemented by using professional inspection bodies.

“This amendment allowing third-party inspections has previously been implemented in the petroleum and natural gas sector as well as most recently been introduced in the Food Safety and Standards Act,” added Jauhri.

The report of the Planning Commission’s steering committee on Ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) sectors recommended that “the states may be supported to utilize professional inspection bodies whose competence to inspect establishments for compliance to AYUSH regulations can be established by way of their accreditation by NABCB to the applicable international standards.”

The panel was headed by Planning Commission member Syeda Hameed and R.A. Mashelkar, former director general of the Council of Scientific and Industrial Research, the country’s largest publicly funded research body.

According to the Drugs and Cosmetics Act, 1940, the inspection of all drug manufacturing units is required to test for compliance to good manufacturing practices (GMP) and other regulatory requirements.

Currently, this is done by inspectors at government agencies, including the Central Drugs Standard Control Organization, the State Food and Drug Administration and the department of AYUSH. Health ministry officials could not be contacted by phone on Monday and Tuesday.

Emails sent to joint secretary, Arun Kumar Panda, and the secretary of the department of AYUSH, Anil Kumar, did not elicit any response.

In the AYUSH sector, the commission’s recommendation is more relevant. Mint last week reported that despite the government’s efforts to raise the quality of traditional Indian medicines, many makers of Ayurveda, Unani and Siddha drugs were yet to comply with prescribed standards, including safety tests, quoting a study by TÜV SÜD, a German quality certification, inspection and testing company. The Food Safety and Standards Authority of India, which regulates the food sector, has already recognized seven third-party auditors to inspect food and food processing units for sanitary and hygienic requirements, among other duties.

Jauhri said the importance of third-party inspection lies in the fact that it puts the onus to comply with the regulatory requirements on the industry as opposed to the regulator, who will have to only check for compliance. “This creates a middle layer that has so far been missing from the regulatory framework,” Jauhri said.

The regulator, though, will “retain the right to directly inspect the manufacturing unit for any valid reason”, states the recommendations of the Planning Commission report.

Globally, governments seem to be recognizing the role of third-party inspections; the European Union requires all regulators to rely on accredited third-party institutions for auditing and compliance.

Pankaj Jaiminy, assistant vice-president (food and agri services) for quality testing, certification and inspection at the South Asian unit of TÜV SÜD, said there are at least 120 certification firms in India. “In healthcare certification, there are around 40-45 firms which can undertake audits competently,” he said.

TÜV SÜD South Asia, after being recognized to undertake inspections or audits of food business operators, plans to double its workforce in this area from the existing 40 auditors. “Currently, it is not too easy to find qualified people, especially at senior levels such as lead auditors,” said Jaiminy. But as demand rises, more people will look at it as a career opportunity, he added.

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