Centre directs manufacturers not to use excipient propylene glycol supplied by Maya Chemtech

Our Bureau, New DelhiThursday, March 16, 2023, 08:00 Hrs  [IST]

The Central government has asked the drug licensing authorities of the states and Union territories to direct the pharmaceutical manufacturers not to use the excipient propylene glycol supplied by Delhi-based Maya Chemtech India Pvt Ltd, in connection with the cough syrups which has allegedly resulted in adverse events and death of children in overseas.

The government has also informed that tests conducted on the samples from Noida-based Marion Biotech, which has been allegedly resulted in adverse events in Uzbekistan, has revealed that out of the 30 drug samples from the company tested, 24 samples were declared as Not of Standard Quality (NSQ) and out of that, 22 samples fall under the category of adulterated or spurious.

The Ministry of Uzbekistan alleged that the cough syrup manufactured by Marion Biotech has resulted in the death of 18 children.

Commenting on the issues related to the death of children in Gambia and Uzbekistan, which has raised questions on the quality of drugs manufactured and exported from India, Bhagwanth Khuba, minister of state in the ministry of chemicals and fertilisers informed Rajya Sabha, “the sample of excipient ‘Propylene Glycol’ was declared NSQ by Government Analyst, Chandigarh and was found not conforming to claim as per IP 2018, Addendum 2021 in respect to Identification. The sample was found to contain ethylene glycol (EG).”

Further, during joint investigation, it was observed that Maya Chemtech India Private Limited, Delhi was mainly the supplier of propylene glycol which has been used in the impugned batches.

“Accordingly, an alert has been issued on March 7, 2023 to all State/UT’s Licensing Authorities for issuing directions to manufacturers, not to use propylene glycol supplied by Maya Chemtech India Private Limited, Delhi in public interest,” said the Minister.

The Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at Marion Biotech Pvt. Ltd. to ascertain the facts that allegedly led to the death of children in Uzbekistan. Drug samples were drawn from the manufacturing premises under the provisions of Drugs & Cosmetics Act, 1940 for test & analysis. Further, the manufacturing license of the firm was suspended by the State Licensing Authority, Uttar Pradesh on January 9, 2023.

“The Regional Drug Testing Laboratory (RDTL), Chandigarh has forwarded the test reports of 30 drug samples so far, wherein 24 samples of drugs/raw material were declared as "Not of Standard Quality''. Out of these 24 samples declared as "Not of Standard Quality '', 22 samples fall under the category of adulterated/spurious under Section 17A and 17B of the Drugs and Cosmetics Act, 1940, which can cause grievous hurt to patients. An FIR has been lodged on 02.03.2023 in the concerned police station and three persons have been arrested,” said the Minister.

During the joint inspection, it was revealed that Marion Biotech has obtained permissions for the product DOK 1 Max syrup (paracetamol, guaiphenesin and phenylephrine hydrochloride cough syrup), DOK 1 Max tablets (paracetamol, guaiphenesin and phenylephrine hydrochloride tablet) and ambronol syrup (ambroxol syrup) for export purpose only.

Elaborating on the allegations by the World Health Organisation (WHO) that the cough syrups manufactured by Haryana-based Maiden Pharma has resulted in death of 66 children in Gambia, the Minister said that as per the information received from CDSCO, the Committee set up by the Department of Health and Family Welfare has submitted its report; The committee observed that several important information is not available for establishing the causality; The limited information provided by WHO was analysed by the committee and found to be inadequate.

As part of the summary of the adverse events, WHO has classified the event as acute kidney injury (AKI) secondary to E. coli infection compounded by medication associated poisoning and it was mentioned to be a working hypothesis.

The committee, however, observed that the test results from RDTL, Chandigarh have demonstrated that the four samples in question were of standard quality and negative for diethylene glycol (DEG) and ethylene glycol (EG).

“On overall perspective taking into view all the information as available from WHO and CDSCO, the committee opined that there is no causal relationship that could be established between the deaths in Gambia and the products manufactured by Maiden Pharmaceuticals Limited, Haryana,” said the Minister.

The control samples of the four cough syrups from the company were drawn and sent for test and analysis to Regional Drug Testing Laboratory, (RDTL) Chandigarh by the investigating team. As per report of the Government Analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both diethylene glycol (DEG) and ethylene glycol (EG) meaning thereby that the excipients used were not contaminated with DEG & EG. However, the state drugs controller has asked the company to stop all manufacturing activities at Sonepat with immediate effect on October 11, 2022, in public interest.

Meanwhile, as per information received from state drug controller, Kerala, five drug formulations of Maiden Pharmaceuticals Limited, Sonepat, Haryana were reported as NSQ and necessary steps were taken to prevent the sale of the drug available in the market.

As per information received from Commissioner, FDCA Gujarat, one formulation manufactured by Maiden Pharmaceuticals Limited, Himachal Pradesh failed in quality test and the matter was referred to drugs controller, Himachal Pradesh for investigation and necessary action.

As per information received from state drug controller, Bihar, the state health society, Bihar had blacklisted the firm Maiden Pharmaceuticals Limited on February 10, 2011. Earlier in 2013, CDSCO had received information from Drug Administration of Vietnam regarding blacklisting of Indian pharma companies for alleged quality violations, in which one of the manufacturers was Maiden Pharmaceuticals Limited, India for drug omeprazole 20 mg (Omepro) manufactured and exported to Vietnam, said the Minister.