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The Dangerous Cocktail Of Substandard Drugs And Poor Regulatory Oversight In India

Last week, the Health Ministry suspended an official of India’s drug regulatory body the Central Drugs Standard Control Organisation (CDSCO) after he was arrested by the Central Bureau of Investigation (CBI) on charges of corruption.

According to a statement by Health Ministry — Dr. Naresh Sharma, Deputy Drug Controller (I) at CDSCO headquarters in New Delhi has been “trapped” and was taken in custody by the CBI on August 16 for investigation.

“All stakeholders, public and officers shall take cognizance of the fact that CDSCO has the policy of zero tolerance towards corruption and is committed to act stringently against any act of corruption,” the Healthy Ministry said in a statement.

There were no details of the specific corruption charges.

Sharma joined CDSCO in November 2006 after over five years in Dabur Research Foundation. He also previously worked in research and development departments at Cadila Pharmaceuticals, JK Drugs and Pharmaceuticals and Paam Pharma.

But his arrest coincides with CBI unearthing a major corruption racket where it booked a CDSCO inspector based in Himachal Pradesh. He was allegedly took a bribe, to approve a substandard drug.

CBI sleuths have found samples of dobutamine injection made by Amritsar-based Kwality Pharmaceuticals by the firm, which had failed CDSCO trial. But, the drug inspector agreed to approve the samples, in connivance with officers at the Delhi headquarters in exchange for Rs 1 lakh bribe.

The agency arrested drug inspector Ankur Bansal, based in Solan in Himachal Pradesh, and some employees of Kwality Pharmaceuticals including its managing director Ramesh Arora.

This is not the first case of corruption. However, the involvement of certain elements at highest level of the Indian regulatory body involved in the cases of graft is definitely alarming.

Substandard drugs 

To be sure, the substandard dobutamine injection that Kwality Pharmaceuticals allegedly tried to push through the cracks, is a life-saving drug used for patients suffering from heart failure. If the drug does not work as desired, the patient could die.

Substandard drugs have become a major problem. The World Health Organisation (WHO) has estimated that one in ten medical products in low-and-middle-income countries is substandard or falsified. This includes India.

A substandard drug may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient. They are also laden with impurities, much higher than the acceptable range.

Other concern WHO raises about substandard and falsified medical products is antimicrobial resistance and drug-resistant infections.

These drugs are out there in the market, because the companies producing them, does not follow current good manufacturing practices and take short cuts for profits, and regulators’ poor oversight, in some cases like Kwality Pharmaceuticals it could be just a case of deliberate overlook.

News agency PTI, had in June reported that the The Bureau of Pharma PSUs of India (BPPI), which implements Jan Aushadhi scheme, has found 25 batches of drugs of 18 different pharmaceutical companies to be of substandard quality since January 2018, quoting an official document.

While 17 out of the 18 companies are private, one is a public sector unit (PSU) — Indian Drugs and Pharmaceuticals Ltd (IDPL).

The government needs to strengthen its GMP inspections, weed out manufacturers who are not adhering to the quality standards. We need to have surveillance and monitoring systems, to check the quality of the drugs in the market.

Indian should move towards adopting Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP), to ensure harmonisation.

The government reluctance to adopt PIC/S is said to protect the industry, especially the medium and small pharmaceutical manufacturers, is not convincing. Quality comes with a cost. Too much focus on lowering prices rather than assuring highest quality of drugs sold in the country is also becoming a problem.

There is nothing big for the government than the health of its citizens. There should zero tolerance of substandard drugs and those who manufacture and approve them. – Money Control

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