As govt readies plans to test drugs before export, industry stresses on quality management

In order to check adulteration, the government plans to test drugs prior to export.

Aiming to curb the export of spurious drugs, including cough syrups, a top health ministry official said that the government is considering putting in place a system for testing drugs prior to export. The union health ministry, along with the Department of Pharmaceuticals, and Directorate General of Foreign Trade (DGFT), have started deliberations on this.

The official told Moneycontrol that a proposal for additional quality checks by the apex drug regulator is under "active consideration".

“The samples of drugs meant for export are to be tested before they are shipped out. This has been proposed by the union health ministry and the Department of Pharmaceuticals, and even DGFT officials will be part of the discussion,” the official added.

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The official said that cough syrups meant for export may be sent for additional quality checks in regional or central drug testing labs before they are exported. He, however, added that the "implementation will take some time".

In recent times, adulterated drugs exported by domestic pharma companies have been a cause of concern for the Indian government.

In the last six months, the World Health Organisation (WHO) has issued Medical Product Alerts for substandard Indian cough syrups exported to The Gambia and Uzbekistan, containing unacceptable amounts of the contaminants diethylene glycol and ethylene glycol.

Over-reliance on testing not good

Dr Viranchi Shah, National President, Indian Drug Manufacturers Association (IDMA), stressed on developing a quality management system as provisions for analysing and testing every batch before export is already there.

“In the modern world, over-reliance on testing should not be our goal. The goal should be to build a quality management system. As an industry, we are also internally interacting on how we work with the government to strengthen the quality management system,” he said.

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"Even if it’s done (testing before export), as an association, we don’t have any problems, as we have always encouraged our members to adopt the best quality management standards,’’ he added.

Shah said there was nothing wrong in putting in place additional checks for drugs meant for export or domestic use.

“Random sampling has always been part of the monitoring process. India is the third largest manufacturer, half of our produce goes to the US and European markets. We have proved over the decades that we manufacture good quality and affordable products,” he added.

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Welcoming the move, Vivek Sehgal, former Director General, Organisation of Pharmaceutical Producers of India (OPPI), said any regulatory change should not be of concern to the industry as it helps build quality systems.

“This is an important decision. Any regulatory change for the improvement of quality is definitely a welcome step from the industry's perspective, and more importantly, from the patient's perspective,” he added.

Implementing Schedule M to boost drug quality

The Pharmaceuticals Export Promotion Council (Pharmexcil), an arm of the ministry of commerce, which has been acting against erring pharma firms for supplying substandard drugs abroad, said strengthening of good manufacturing practices across India should be a priority.

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Uday Bhaskar, Director General, Pharmexcil, said the government should work for the implementation of Schedule M of the Drugs and Cosmetics Act, 1940, which deals with good manufacturing practices that should be followed by pharmaceutical manufacturing units in India.

“Every manufacturer has different products. How is it humanly possible to check lakhs of samples before they are exported?” Bhaskar said.

He further asked how the manufacturer would be assured that his product isn’t stuck (in the queue for testing) prior to export. “The volume of products being exported is huge. Every product has a limited shelf life of one year or a little more. If the product is stuck due to the testing of samples, what will the manufacturer do,” he queried.