New Delhi : The Drugs Controller General of India (DCGI) has directed the manufacturers not to submit the same batch of cough syrup to more than one laboratory at a time, which the regulator finds as highly objectionable and not acceptable.
The drug regulatory authority has been facilitating testing of cough syrups that are to be exported based on a notification on May 22 by the Director General of Foreign Trade (DGFT) amending the export policy of cough syrup from free exports to the mandate that the cough syrup shall be permitted to be exported from June 1, 2023, subject to the export sample being tested and the Certificate of Analysis (CoA) issued by certain laboratories to be submitted.
The DCGI, in letter to all drug manufacturers associations and exporters said that it has come to its notice that cough syrup samples of the same batch number manufactured by the same manufacturer (for export purpose) are being received by two different laboratories for testing purposes, “which is highly objectionable and not acceptable”.
“…it is hereby directed that no manufacturer/exporter shall submit the same batch numbers of cough syrup manufactured by them to two or more laboratories,” it said.
“If such cases are reported further, the samples of those manufacturers/exporters shall not be accepted for testing by any of the NABL accredited government laboratories,” cautioned the DCGI.
The DGFT notification enlisted the laboratories, including the Indian Pharmacopoeia Commission (IPC), Ghaziabad, Central Drugs Laboratory, Kolkata, Central Drugs Testing Laboratories (CDTLs) in Chennai, Mumbai and Hyderabad, Regional Drugs Testing Laboratories (RDTLs) in Chandigarh and Guwahati and any NABL accredited State Drugs Testing Laboratory to conduct tests and issue the CoAs.
The submission of samples in the laboratories enlisted by the DGFT for CoAs has anomalies, with some laboratories such as the Indian Pharmacopoeia Commission (IPC), Ghaziabad and the Central Drugs Testing Laboratory, Mumbai burdened with more number of samples while some other laboratories have not received a single sample for testing.
The industry has complained that the compulsory testing has put its exports timeline into jeopardy, with the consignments awaiting results from these laboratories for several days. One possibility for the current confusion and submission of samples in multiple laboratories may have to do with the companies trying to get the CoA from one of the other laboratories at the earliest.
It may be noted that the confusion exists even after the CDSCO started uploading the daily updates of the number of batches of cough syrup samples submitted with each of the laboratories prior to exports, in its website in order to enable timebound testing and release of reports.
While the update started happening in June, this year, at least twice the CDSCO had to ask the companies to stop submitting any sample of cough syrup to the CDTL Mumbai facility and the IPC, Ghaziabad since they were having more than 100 samples under testing at a time. This happened at a time when some of the laboratories did not have a single sample tested during the time.
According to the daily update by the CDSCO, the regional drug testing laboratory in Chandigarh has 82 batches waiting for analysis, followed by 69 in the State laboratory of Hujstsy with 69 batches and CDTL Mumbai with 55 and IPC Ghaziabad with 49 batches of samples, on August 1, 2023. The number of batches pending for test on July 31 for Mumbai laboratory was 77 and IPC, Ghaziabad was 52.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) (DCGI), has informed all drug manufacturers’ associations and exporters in June that it has decided to publish the number of batches of cough syrup samples received at each of the Central and state drug testing laboratories on a daily basis on the CDSCO website.
“This is to enable work distribution amongst the lab and for release of test reports in a time bound manner by these laboratories,” said Raghuvanshi. Accordingly, the drug manufacturers and exporters may refer to the daily list and submit the sample to the laboratory having fewer samples as compared to other labs, he added in a circular.
According to reports, the DCGI has also issued standard operating procedures in May, to streamline the processes of testing in the laboratories and ensure the standard quality across the laboratories.
The measure comes after the reports and medical alerts from the World Health Organisation (WHO) and others that the cough syrups exported from the country has resulted in adverse events and death of several children in some of the countries.
WHO has earlier alleged that the cough syrup exported from India has resulted in death of children in Gambia and Uzbekistan and the Indian drug regulator conducted tests on the samples from the companies which were allegedly involved in the export of these cough syrups. This, along with reports of an adverse event from the United States against an ophthalmic product manufactured in India, has raised concerns over the quality of drugs exported from the country and the Government of India started various actions to ensure quality of medicines.