DCGI tells drug firms to self-assess compliance, submit audit reports
New Delhi: Drug makers will now have to self-assess their compliance with good manufacturing and laboratory practices (GMP/GLP), award themselves a quality rating and submit an audit report to the state drug regulator, a move aimed at improving manufacturing practices in India.
A checklist has been put together by the Central Drugs Standards Control Organisation (CDSCO) to help manufacturers perform GMP-GLP evaluations.
The Drug Controller General of India (DCGI) in an order on Wednesday directed manufacturers to submit the self-assessment reports of their units along with self-certification, stating that they are complying with GMP/GLP requirements as per the Drugs and Cosmetic Rules and submit plans for remedying any violations by 30 August.
According to officials in the DCGI, a 40-page checklist and evaluation tool has been shared with manufacturers to help them understand the standards to be maintained and ensure the safety and efficacy of medicines manufactured in India.
“The checklist includes an elaborate tool kit for verification GMP/GLP along with benchmarks based on the concept of rating manufacturing units on the basis of an estimated risk that they pose to users. This practice will be eventually followed by regular checks by the state drug controllers,” a senior official said on condition of anonymity.
The move could help prevent the spread of sub-standard drugs. In a government survey last month, some major pharma companies failed a test for Not of Standard Quality (NSQ) survey. The survey reported that 3.16% of drug samples taken from retail outlets were not of standard quality.
According to the survey, 10.2% of drugs from government sources were NSQ and 0.059% were spurious.
A spokesperson for Pfizer said: “We welcome any move that can further strengthen the quality assurance of medicines made available in India. We remain committed to working with our partners to ensure adherence to all applicable quality standards.”
An email sent to Abbott, Cadila remained unanswered at the time of going to press.
While self-assessment will help keep a check on companies and manufacturing units, an industry analyst said self- certification will not necessarily improve the situation.
“Our country has been subjected to increasing inspections by global regulatory bodies and while self-assessment will not be an issue with the major pharma companies, the challenge will remain with the small and medium sized enterprises that are run by 2-3 promoters without professional managers,” said an industry expert who declined to be named.
However, Daara B. Patel, secretary general, Indian Drug Manufacturers’ Association, said that it was a step in the right direction, “Once manufacturers get used to self-regulation and self-certification, it would be easier for them to gear up for various global regulatory audits. In fact, the various toolkits/checklists for GMP Compliance provided by the DCGI for self-assessment would be of great help and advantage,” he said in an email.
Importantly, manufacturers will also have to be careful while claiming adherence to GMP. “As per the Drugs and Cosmetics Act in India, in case of any misleading claims made by a manufacturer, the concerned drug is considered as misbranded and hence under Section 18, it is considered as a criminal offence,” added Patel.