Triggered by the World Health Organization’s (WHO) alert linking made-in-India cough syrups to the deaths of children in Gambia, the government has directed all drug regulators to ensure prescribed standards to test the quality of drugs are followed, News18 has learnt.
According to WHO, laboratory analysis of the syrups manufactured by Sonipat-based Maiden Pharmaceuticals confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
In a letter to drug regulators of state and Union Territories, the Drug Controller General of India (DCGI) has endorsed the letter written by the Indian Pharmacopoeia Commission (IPC), to test drugs using the prescribed standards to maintain the quality of drugs.
IPC is an autonomous institution under the Ministry of Health and Family Welfare, which is responsible to set standards for medicines in the country.
DCGI, VG Somani, in his letter dated October 10, has directed the drug regulators to ensure the use of Indian Pharmacopoeia Reference Standards (IPRS) and impurity standards for the quality testing of drugs.
Somani’s communication encloses the letter issued by the IPC, which he labels as “self-explanatory”. There are 660 IPRS and 345 impurity standards listed in the IPC catalogue and the details are available on the IPC website, he added.
Earlier too, one had to ensure that use of reference standards and impurity standards of IPC by pharmaceutical manufacturers and testing laboratories are followed. Now, “you are requested once again to do the needful for the use of reference standards and impurity standards of IPC as per the Drugs and Cosmetics Act 1940 …” he added.
Letter by IPC
According to the letter written by Dr Rajiv Singh Raghuvanshi, secretary-cum-scientific director, IPC, to the DCGI on October 7, the commission has recently developed a total of 1000 IPRS and impurity standards.
“IPC is also making efforts to promote the use of authentic copies of IP 2022 by the pharmaceutical manufacturers and drug testing laboratories for which awareness programmes for stakeholders are being organised by IPC across India,” the letter read.
Raghuvanshi also informed DCGI that IPC is the only supplier of such standards in India and has not authorised any other party for their distribution.
The letter was sent to DCGI along with Dr Mandeep Bhandari, joint secretary, of regulations at the health ministry.
The Centre has also formed a four-member committee to look into the matter headed by YK Gupta, vice chairperson, Standing National Committee on Medicines. Other members include Dr Pragya Yadav, National Institute of Virology, Pune, Dr Arti Behl from division of epidemiology at National Centre for Disease Control and AK Pradhan, joint drug controller.
The committee will advice DCGI on further course of action after analysing and examining the reports submitted by WHO and collected by regulators in India.
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