oppn parties Lax Regulation Responsible For 'Killer' Syrups?

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Lax Regulation Responsible For 'Killer' Syrups?

By Linus Garg
First publised on 2022-10-07 14:10:59

About the Author

Sunil Garodia Linus tackles things head-on. He takes sides in his analysis and it fits excellently with our editorial policy. No 'maybe's' and 'allegedly' for him, only things in black and white.

A report by Ayushman Kumar in moneycontrol.com informs how Maiden Pharmaceuticals, the Haryana-based drug manufacturer now in the eye of a storm for selling substandard (contaminated) paediatric cough syrups to Gambia which allegedly resulted in the death of 66 children in that country and forced WHO to issue a global alert, has a past history of being reported for selling substandard products. The report highlights the fact that Vietnam had blacklisted the firm for that reason and Indian states like Kerala, Gujarat and Bihar had, at different times, either flagged the firm for supplying poor quality drugs or blacklisted it.

Yet, Maiden Pharmaceuticals has been doing roaring business and had also got the permission from Indian drug regulators to manufacture and export the four cough syrups now under the scanner. WHO has reported that preliminary tests have confirmed that the syrups were found to contain excessive levels of diethylene glycol and ethylene glycol, much beyond the permissible level. The two chemicals are mainly used as solvents in industries and are not fit for human consumption. They can damage the kidneys, especially in children and cause fatalities. 

It is indeed surprising that a company that has regularly been reported for supplying substandard drugs was allowed to manufacture the syrups and export them. The company could have used the two substances in the syrups as they are much cheaper than glycerol or glycerine which is a component of most cough syrups.  Infact, such adulteration is common and WHO mandates a compulsory DEG test before these drugs are exported. It is clear that such a test was either not performed or not done properly in India, at least in the batch that is under the scanner. The company has denied using excessive diethylene glycol and ethylene glycol and has alleged that the syrups were adulterated elsewhere. Meanwhile, state drug regulator in Haryana has collected the samples of the four syrups and sent them for analysis in the Central Drug Laboratory in Kolkata.

The incident once again shows that drug regulation in India is lax. Monitoring and inspection of manufacturing processes of drug manufacturers is not done on regular basis. In fact, some manufacturers escape scrutiny for years. Corruption is rampant. India needs to first update its archaic drug laws. Then it needs to implement a stringent good manufacturing practises (GMP) framework. It needs to fund its drug regulator well to ensure that it has trained staff in good numbers to conduct periodic checks on manufacturing facilities of pharma companies, especially of small units who are more likely to indulge in adulteration. Just making cheap generic drugs in abundance and being the largest supplier of such drugs worldwide is not enough. If India does not ensure (through strict regulation and continuous monitoring) that its drug manufacturers adhere to GMP and supply drugs that meet international standards, it will not be long before export orders will dry up.