Drugmakers to face tougher quality rules: Failed a test? Re-do the exam.

The Centre plans to suspend the product permission licence issued to a drugmaker for a particular medicine if even a single batch of that medicine is found to be substandard by any government testing laboratory, said two officials, requesting anonymity.

In effect, a drugmaker will not be allowed to continue manufacturing a particular medicine after just withdrawing a failed batch, as is the current practice.

India’s Drugs Rules, 1945 has no provision on actions to be taken if a batch of medicines fails a quality test, apart from those specific medicines being declared as not-of-standard-quality (NSQ). A drugmaker’s licence for that particular drug or product is suspended only if an investigation establishes wrongdoing on the part of the company—an often lengthy process. 

The Union government’s proposed rule changes would also have a bearing on the global pharmaceutical industry. India, which manufactures 60,000 generic brands across 60 therapeutic categories, is the largest global supplier of generic drugs, accounting for about 20% of the global supply.

Given the lacuna, state governments resort to ad-hoc actions, and in the process fail to check subpar manufacturing practices that have dented India’s image as the “world’s pharmacy".  

States and union territories are empowered to take action against a drugmaker if a batch of medicines fails a quality check. This includes asking a manufacturer to withdraw a product or suspending the product permission licence if an investigation finds the drugmaker at fault, but these are often not implemented uniformly.

“According to the new plan, once a drug is declared NSQ, the company cannot produce another batch while the investigation is going on, the loopholes are fixed, corrective measures are taken, and regulatory authorities are satisfied with the corrective measures," said one of the officials cited above. “This is a lengthy process and may take many years."

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The amendment

The Union health ministry will shortly issue a draft notification based on recommendations from India’s top drug panel, the Drugs Technical Advisory Board (DTAB), according to the second of the two officials mentioned above.

Accordingly, the government plans to amend the Drugs Rules to allow for the immediate suspension of the licence for a medicine that has failed a quality check until the company submits a corrective action and preventive action (CAPA) plan, which has to be approved. All states and union territories will have to follow the new rules, the official said.

The suspension on the product licence will only be revoked after a root cause analysis and implementation of corrective measures, according to DTAB’s minutes of a meeting on the issue, which Mint has reviewed.

“This is a very important decision taken by the top drug panel," said the first official quoted above. 

“Right now, the provision is whenever any drug is identified as NSQ, the licensing authority tells the company that this particular drug batch has failed the quality test, and you (company) withdraw the product from the market. And later an investigation is carried out. In such a case, the manufacturer can go on producing the subsequent batches of the drug. So, there is no restriction on the manufacturer," the official said.

A spokesperson for the Union health ministry pointed out that improving the quality of drugs identified as substandard takes time.  

“To improve the situation, it is being proposed that once NSQ is identified, the manufacturer of the NSQ product will be requested to find out the root cause for the failure leading to NSQ, formulate a corrective plan, and demonstrate through validation the workability of the improvement plan," the spokesperson said in response to a query from Mint. . 

“Till this happens, the manufacturing licence for the concerned product will be under suspension and will be revoked once satisfactory solution is demonstrated to the regulator."

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‘Not just a quality issue’

The government’s plan has come as a shocker to India’s $50 billion pharmaceutical industry, which insists that a particular batch of medicines could fail a random test for reasons other than poor quality.

“We respect the DTAB’s decision as we understand that they are trying to do something to control NSQ. However, we don’t think it is a very good idea to suspend the product permission license as soon as a drug is declared NSQ. There needs to be a thorough investigation before that)," said Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association, which represents more than 1,000 pharmaceutical companies. 

“A product can fail due to many reasons such as analytical error, labelling issue, storage or manufacturers issues, or it could be spurious (and may not be manufactured by the original company," Shah said. “The basic principle to suspend the product permission license is ok until CAPA is done, and we are not against that. However, it should be done with proper checks and balances, and the root cause has to be identified."

The government’s plan, however, assumes significance considering that 2,988 drug samples were declared to be ‘not of standard quality’ in 2023-24, and 282 drug samples were found to be spurious or adulterated, according to a response by the government in Parliament.

“Suspending the product permission license is the right thing to do," said Dr. R.V. Ashokan, past president of the Indian Medical Association. “If a manufacturer cannot ensure the quality of the drug, then they should not do business in this area. Already there is no control on spurious drugs and regulation has failed to stop that. At least in the case of NSQ, the regulatory authorities have the licence with them to control manufacturers."

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