DCGI Warns Of Stringent Action For Quality Lapses As International Community Started Doubting Indian Drugs

Chennai : Hailing the stellar performance of the Indian pharmaceutical industry on one side but raising quality concerns on the other in the wake of quality alerts issued by WHO on India made cough syrups and eye ointments a few months ago, the Drug Controller General of India (DCGI) has wanted the drug manufacturers of South India to focus their attention on the quality aspect as the core area of drug production.

The DCGI has warned all the manufacturers that any lapse in the quality control mechanism will be viewed seriously and strict regulatory action will be initiated against the erring companies.

Delivering a talk on the subject, “Pharmaceutical Quality — What are we missing?”, in a seminar organized as part of the Pharmac South Expo in Chennai, Dr. Rajeev Singh Raghuvanshi, the national drug regulator, said that poor quality of drugs exported from India to foreign countries have tarnished the image of the country in the international market. He said pharmaceutical quality has become a subject of discussion in the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He said companies who manufacture poor quality medicines for domestic as well as for global markets will have to face stringent action from the national drug regulatory office and there will not be any compromise on his part. He reminded the manufacturers that the central agency has the equal rights to audit the manufacturing plants as with the state regulators. According to him, the manufacturers produce two categories of drugs, one category for exports and another one for domestic purposes. This method of manufacturing drugs in two baskets cannot be recognized.

But he said the issue of NSQ or substandard or spurious or whatever it may be is not because of one product or of a single company, it is due to the system followed by the companies. A systematic change for hundred percent compliance to quality mechanisms is required in the process of production by all manufacturers to restore the faith of the international community. He said the central regulators will not wait for deaths to happen due to poor quality drugs for initiating action, the joint inspection recently started as a campaign will continue for long.

“We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders,” he pointed out.

Pointing to the cough syrup contamination and the international health organization’s quality alerts, Dr. Raghuvanshi said the central drug control administration has started a joint campaign, a risk-based inspection, with state regulatory departments, but it brought a dismal result which showed the MSME sector as the culprit. According to him hundred percent of the quality issues have emerged from the MSME sector. He said all over India there are 10,500 MSME units engaged in the production of drugs, but several of them lack skill deficiency.

As regards the risk-based inspections, he said CDSCO has chalked out a framework for the inspections which is based on historical data of the NSQs drawn by central and state regulators. In a national survey conducted on MSMEs, it was found that 209 companies were having more than 10 NSQs. Companies having more than 70 NSQs within a period of certain years were found that their production processes were worse.

Dr. SV Veeramani, chairman of the Pharmexcil introduced the DCGI to the south Indian manufacturers and J Jayaseelan, chairman of the TN IDMA gave a warm welcome.

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