Centre issues alert to all licensing authorities to ask pharma firms not to use Maya Chemtech's propylene glycol
The sample of excipient propylene glycol was declared not of standard quality by government analyst Chandigarh and the sample was found to contain ethylene glycol, Khuba said.
New Delhi: The central government has issued an alert to all licensing authorities of states and Union Territories to ask pharmaceutical firms not to use propylene glycol supplied by Maya Chemtech India Pvt Ltd, the Rajya Sabha was informed on Tuesday.
The Delhi-based firm supplied the excipient to Marion Biotech -- allegedly linked to the cough syrup deaths of children in Uzbekistan.
In a written reply, Minister of State of Chemicals and Fertiliser Bhagwanth Khuba said the Central Drugs Standard Control Organisation (CDSCO) and State Drugs Controller, Uttar Pradesh, conducted a joint investigation at Marion Biotech Pvt Ltd, Noida and collected samples for tests.
Regional Drugs Testing Laboratory (RDTL), Chandigarh has forwarded the test reports of 30 drug samples so far, wherein 24 samples of drugs/raw materials were declared as "not of standard quality", with 22 samples falling 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, the minister said, adding an FIR was also filed and three persons were arrested.
The sample of excipient propylene glycol was declared not of standard quality by government analyst Chandigarh and the sample was found to contain ethylene glycol (EG), Khuba said.
During the joint investigation, it was observed that Delhi-based Maya Chemtech India Pvt Ltd was mainly the supplier of propylene glycol, which has been used in the impugned batches, the minister said.
"Accordingly, an alert has been issued on March 7, 2023, to all State/UTs licensing authorities for issuing directions to manufacturers, not to use Propylene Glycol supplied by Maya Chemtech India Pvt Ltd, Delhi in the public interest," he said.
He said Marion Biotech had 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.
Marion Biotech had come under the scanner in December last year for its cough syrup Dok-1 which is suspected to have led to the death of 18 children who consumed it in Uzbekistan after which the CDSCO launched a probe into the matter.
The minister further said in the case of the deaths of children in Gambia, the committee set up by the Department of Health and Family Welfare has opined "that there is no causal relationship that could be established between the deaths in Gambia and the products manufactured by Maiden Pharmaceuticals Ltd, Haryana".
The committee observed that several important pieces of information are not available for establishing the causality and the limited information provided by WHO was analysed by the committee and found to be inadequate, he added.
Also, the committee 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 Ltd, Haryana," Khuba said.
A joint investigation by CDSCO and State Drug Controller, Haryana, revealed that the company was given a license to manufacture four drugs -- Promethazine Oral Solution BP, KOFEXMALIN Baby Cough Syrup, MaKOFF Baby Cough syrup and MaGrip n Cold Syrup, for export purpose only.
Last year in October, Maiden Pharmaceuticals had come under the scanner after the WHO alerted that the firm's cough syrups could potentially be linked to the death of 66 children in Gambia.
In his reply, the minister said as per information received from State Drug Controller, Kerala, five drug formulations of Maiden Pharmaceuticals Ltd, Haryana, were reported as not of standard quality and necessary steps were taken to prevent the sale of balance portions of drugs available in the market.
Similarly, as per Commissioner, FDCA Gujarat, one formulation manufactured by Maiden Pharmaceuticals Ltd, Himachal Pradesh failed in the quality test and the matter was referred to Drugs Controller, Himachal Pradesh, for investigation and necessary action, he added.
Khuba further said State Drug Controller Bihar, the State Health Society, Bihar, had blacklisted Maiden Pharmaceuticals Ltd, Haryana, on February 10, 2011.
"Earlier in 2013, CDSCO had received information from the 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," he added.
