Uzbek cough syrup deaths: DCGI issues alert against supplier of Marion Biotech

A representative of Maya Chemtech, who spoke on condition of anonymity, said the company did not sell the raw material to Marion for pharmaceutical products, but cosmetics.

India’s federal drugs regulator has directed state drugs regulators to ensure local manufacturers do not procure raw material, propylene glycol, from a Delhi-based firm that supplied the ingredient to Noida based Marion Biotech, whose cough syrups were linked to deaths of at least 18 children in Uzbekistan last year.

In December, last year, India launched an inquiry against the Noida based drugs manufacturer after deaths of 18 children in Uzbekistan were linked to consumption of a syrup manufactured by the firm. (HT File)

“It is further informed that M/s Maya Chemtech India Pvt. Ltd… Delhi, was mainly the supplier propylene glycol which has been used in the impugned batches. In view of the above, you are requested to issue directions to all manufacturers in your jurisdiction not to use propylene glycol supplied by M/s Maya Chemtech… Accordingly, you are requested to instruct your enforcement officials to keep strict vigil on the matter and take stringent action as per the provisions of the said act and rules against the offenders in public interest,” read the letter of Rajeev Raghuvanshi, drugs controller general of India (DCGI) issued on Tuesday to all state regulators.

Propylene glycol is a viscous, colourless liquid, which is nearly odourless but possesses a faintly sweet taste. Propylene glycol is expensive and it is believed that companies sometimes mix it with inexpensive diethylene glycol and ethylene glycol for sweetening purposes. Both are highly toxic colourless and viscous liquids.

In December, last year, India launched an inquiry against the Noida based drugs manufacturer after deaths of 18 children in Uzbekistan were linked to consumption of a syrup manufactured by the firm.

A representative of Maya Chemtech, who spoke on condition of anonymity, said the company did not sell the raw material to Marion for pharmaceutical products, but cosmetics.

“We are not the only vendors that supplied to Marion Biotech; but since our company has the food license and not drug license, we were singled out. The truth is our company did not supply the raw material to Marion to create pharma products as this company also makes cosmetics items. We provided glycerine and propylene glycol to them,” he said.

This person added that even this was not made by them.

“We don’t have a manufacturing plant; we are only traders . The onus lies on the company creating products from that raw material to test it before use, especially if developing drugs.”

“The drugs regulator has asked pharma companies to not procure from us which we have no issues with as we didn’t want to supply for pharmaceutical production to begin with.”

DCGI’s letter also mention that of the 24 drugs samples lifted from Marion Biotech that failed quality testing, 22 fell under adulterated/ spurious category.

“RDTL (regional drugs testing laboratory), Chandigarh, has now forwarded the test reports of 30 drug samples, wherein 24 samples were declared as not of standard quality and out of these samples 22 samples fall under category of adulterated/spurious under section 17A and 17B of the Drugs & Cosmetics Act, 1940,” read DCGI Rajeev Raghuvanshi’s letter to states.

“This is with reference to investigations conducted at M/s Marion Biotech Pvt Ltd... by the officers of state drugs control department, UP, and CDSCO… in connection with the deaths of children in Samarkand, Uzbekistan. During the course of investigation total 33 samples were drawn by the drugs inspectors of CDSCO…” added the letter. Earlier, the State Security Service of the Central Asian nation started a criminal probe in the matter.

The probe was initiated against the company— Marion Biotech— as the deaths were suspected to have happened after taking its Doc-1 Max tablets and syrup . According to the local media reports, ethylene glycol, was found in the syrup during lab tests.

After being alerted, the central drugs regulatory team asked the Uttar Pradesh drugs licensing authority to initiate the inquiry last year in December. The company is based in NOIDA.

“The company was also issued a show cause notice after the initial inspection as the company was found defaulting on schedule M- good manufacturing practices (GMP) in production,” said a senior official in the drugs control department, requesting anonymity.

Earlier, a similar incident was reported from The Gambia wherein at least 70 children died likely after consuming cough syrups manufactured by another Indian drugs manufacturer.

In a briefing on October 5, the World Health Organization had issued an alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Haryana-based Maiden Pharma.