Death of Children  in Gambia: Action against the drug regulators called for

Indian pharma company’s contaminated cough syrups have caused death of children in Gambia- Action against the drug regulators called for

cough syrup medicine pharma


Shri Rajesh Bhushan

Union Health Secretary

Dear Shri Bhushan,

The news about an Indian pharma company’s cough syrup products causing the death of 66 children in Gambia has brought discredit to the country’s pharma industry and discredit to pharma exports from India. Even in India, there have been cases of childrens’ deaths in J&K and several other States as a result of use of cough syrups and other drugs supplied by the same company, as well as several others. Against that background, I had requested your Ministry to take action against both the companies and the regulatory bodies at the national level and in the States, as such instances cannot be condoned. My letter ( refers.

I have since come across a report ( that both the Central and the Haryana drug regulators have belatedly woken up after the WHO alert, conducted surprise tests of the company’s drugs and found serious lapses, including total absence of testing by the company and false expiry dates being indicated for the final products, far beyond the validity dates of the ingredient chemicals. These are lapses that have taken away 66 lives of children in another country, where this incident has generated intense anger among the people against Indian drugs (


What surprises me is that both the Central and the Haryana drug regulators have issued show-cause notices to the company, making it look as though that there is nothing wrong with the regulatory bodies’ role in this unfortunate case. This is unacceptable, as the procedure for exporting any medicinal product requires prior approval of the Central drug controller. How did the Central Drugs Standard Control Organisation (CDSCO) clear Maiden Pharma’s export proposal in the first instance, without satisfying itself about the completion of testing and evaluation of the products by the Haryana regulator and by CDSCO itself? Apparently, export clearance was given by them in a routine manner, without compliance with the regulatory protocols.

Unless your Ministry goes to the root of this shameful instance, the country is going to face one embarrassment after another in the matter of pharma exports.

What about the deaths that the medicinal products supplied by Maiden Pharma and several other drug companies caused in J&K, Himachal Pradesh and several other States?

It is ironic that lakhs of helpless persons should languish for years in Indian jails without trial, for petty offences, far less serious compared to some of these pharma companies endangering the lives of the people by supplying untested medicines, an offence punishable under Sections 274-276 of the IPC. During the last few years, it is distressing that the promoters and the senior executives of none of these companies, enjoying political patronage, have been subject to prosecution and penalties under the IPC, which suggests that they are beyond the reach of law! It is equally distressing that the concerned regulators too should be left untouched, despite the seriousness of the lapses on their part.

Many of these drug companies are also known to cause toxic pollution, which in itself has endangered the health of the people in their vicinity.

A recent case of income tax investigation against another pharma company has revealed an unholy nexus between the company and doctors prescribing its drugs. Instead of condemning such practices, I understand that your Ministry is trying to endorse the pharma companies’ marketing practices, a stand that has caused widespread public concern.

In the specific case of Maiden Pharma’s involvement in supplying spurious medicines in Gambia and in the other cases in which similar drugs have caused deaths in India, your Ministry should come clean on the lapses committed by the drug companies, the acts of omission/ commission by the regulators an d the action taken against them.


Yours sincerely,

E A S Sarma
Former Secretary to Government of India


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