Domestic drug regulator plans to inspect firms abroad, like USFDA

The Central Drugs Standard Control Organisation (CDSCO) is chalking out an international road map, while wanting to follow in the footsteps of its American counterpart. The goal of the CDSCO is to inspect pharma companies and their manufacturing units in other countries, especially the US, across Europe, Japan and China. ‘’The national drug regulator would conduct risk-based assessments of companies which supply to India,’’ an official at the CDSCO told Business Standard.

So far, the Indian drug controller has only conducted riskbased assessments of manufacturing units in India. Once it starts inspecting manufacturing units overseas, the Indian regulator’s role would be similar to that of the United States Food & Drug Administration (USFDA). The American regulator routinely inspects pharma companies, across the world including in India, which export to the US.

In fact, last year nine warning letters were issued to Indian pharma companies exporting to the US. Several plants of top drug makers in India have remained shut for years following USFDA inspections.

Risk-based assessment implies the regulator would categorise companies based on their risk levels. Companies facing frequent adverse observations will come under the high-risk category, others will be clubbed as low-risk and mediumrisk firms. India’s pharma-related imports, including formulations, bulk drugs and medical devices, are significant from the US, countries across Europe, Japan and China.

An official explained that a risk-based assessment of manufacturing units would be a way of keeping a check on the quality of drugs or devices once the government begins issuing one-time licences or licence in perpetuity. The government recently proposed a policy to issue a onetime licence to pharma companies, a change from the current practice of issuing a licence every three years.

The Indian regulator, in the past, had tried setting up an office in China. However, this project did not take off. The CDSCO planned to set up an office in Beijing to regularly inspect the quality of bulk drugs that are sent to India.

At least 70 per cent of the bulk drugs are imported from China. It is believed that the government decided against this plan due to lack of workforce.

However, this time the central drug regulator seems more confident. A senior CDSCO official said, “we would somehow create a workforce to undertake risk-based assessment in other countries.” The optimism is despite the regulator running without adequate staff in many states.

Nishant Berlia, chairperson, health committee, PhD Chamber of Commerce, is of the opinion that risk-based assessment by the Indian regulator abroad is necessary. “Even though foreign regulators like the USFDA are robust, they can make mistakes. Assessment by other regulators like the CDSCO will ensure that only good quality drugs are sold in India,” Berlia said. He added that while incidents of low-quality drugs is less in developed economies, scrutiny is required by a foreign regulator.