Indian regulations are very robust and have a zero-tolerance policy: Experts on WHO alert on cough syrups

New Delhi: The WHO's recent alert linking cough syrups manufactured by an Indian pharmaceutical firm to the deaths of children in Gambia is "alarming" and there are some missing links that need to be "investigated", an expert said on Saturday.

The World Health Organisation on Wednesday issued an alert, saying four "contaminated" and "substandard" cough syrups produced by Maiden Pharmaceuticals Limited could be the reason for the deaths in the West African nation.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

"The information from WHO that cough syrups manufactured by an Indian pharma company caused the death of 66 children due to the presence of ethylene glycol is alarming. "There are, however, some missing links that need to be carefully ascertained and investigated," said Professor Y K Gupta, senior pharmacologist and vice chairman of the Standing National Committee on Medicines (SNCM).

Dr Gupta said the first death suspected to be due to the same reason was noted in July.

The Drugs Controller General of India (DCGI) received a communication from WHO on September 29 and the Indian government and the drug regulator immediately swung into action.  The letter was responded to instantly by seeking full details. Despite October 1 being a Sunday and October 2 being a national holiday, investigations were initiated, Dr Gupta explained.

"It is important to understand here that only new drug approval is granted by DCGI whereas license for manufacture and sale is given by state drug controller.

"In this case, the license for manufacture and sale was given by the state drug controller. The company was licensed to export only to this one country and not in any other country or in the Indian domestic market," he told PTI.

The other missing link is that of the 23 samples which were tested by WHO, ethylene glycol was found only in four samples, Dr Gupta said adding, "This is perplexing and needs clarification." "Also, the importing country gets it tested as per defined standards or their pharmacopeia. It seems this was somehow missed," he said.

Indian regulations are very robust and have a zero-tolerance policy in such matters.

So one should not question the alertness of regulators, he said.

The Indian pharma sector is producing drugs and vaccines which are used throughout the world and they are known for quality, and people trust them, he stated.

Such isolated incidence must be thoroughly investigated and action should be taken but they must not be generalized and allowed to cast a bad shadow on the entire drug manufacturer in India, Dr Gupta added.