‘No Uniform Test For Cancer-Causing Substances In J&J Baby Products’ — Drug Regulator Summoned

New Delhi : The National Commission for Protection of Child Rights (NCPCR) Thursday issued summons to the Drug Controller General of India (DCGI) and the Central Drugs Standard Control Organisation (CDSCO) over a lack of uniformity and standardisation in the testing methods for presence of formaldehyde and asbestos in Johnson & Johnson’s baby shampoo and talcum powder respectively.

Both formaldehyde and asbestos have been identified as carcinogen, a substance that promotes the formation of cancer in the body.

This is not the first time that the US pharma giant’s baby products have come under the scanner. In March 2019, drug inspectors in Rajasthan claimed to have found formaldehyde in two batches of ‘No More Tears’ baby shampoo. However, in June that year, the Central Drugs Laboratory (CDL), Kolkata said the shampoo is safe to use.

In 2014, the company had restructured the shampoo and dozens of other products after several consumers raised concerns about the presence of formaldehyde and another potentially harmful substance, 1,4-dioxane.

The NCPCR, a statutory body under the Ministry of Women and Child Development, has asked the DCGI to appear before it on 12 March to explain why the CDSCO has not “regulated the standards and uniformity in the ‘Testing Methods’ done by these accredited laboratories in India”, including CDL in Kolkata and the Regional Drugs Testing Laboratory (RDTL) in Chandigarh.

The DCGI heads CDSCO which comes under the jurisdiction of the Ministry of Health and Family Welfare.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conducting clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations.

‘Need to ensure child rights is protected’

The summons issued by NCPCR refer to a letter from last year, dated 12 March, by CDSCO on details of testing methods. According to the letter, there is no uniformity in the methods used by these labs for testing the presence of formaldehyde and asbestos in J&J’s products.

The letter also states that RDTL tested the talcum powder according to methods prescribed by United States Pharmacopeia, an organisation that develops quality standards for medicines, dietary supplements, and food ingredients in the US and other countries. In order to test the baby shampoo, RDTL used the method validated by Johnson & Johnson.

Meanwhile, CDL Kolkata used methods provided by the US company for testing the baby shampoo for formaldehyde. It also used methods provided by British Pharmacopeia to cross-check results.

The summons have been issued as “it is aptly clear from the above response that there is no uniformity in ‘Testing Methods’ for the purpose of testing the presence of formaldehyde in baby shampoo and asbestos in talcum powder and the same is clearly a mandate of CDSCO to regulate as per the functions of the CDSCO,” the NCPCR notice said.

The DCGI heads CDSCO which comes under the jurisdiction of the Ministry of Health and Family Welfare.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conducting clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations.

‘Need to ensure child rights is protected’

The summons issued by NCPCR refer to a letter from last year, dated 12 March, by CDSCO on details of testing methods. According to the letter, there is no uniformity in the methods used by these labs for testing the presence of formaldehyde and asbestos in J&J’s products.

The letter also states that RDTL tested the talcum powder according to methods prescribed by United States Pharmacopeia, an organisation that develops quality standards for medicines, dietary supplements, and food ingredients in the US and other countries. In order to test the baby shampoo, RDTL used the method validated by Johnson & Johnson.

Meanwhile, CDL Kolkata used methods provided by the US company for testing the baby shampoo for formaldehyde. It also used methods provided by British Pharmacopeia to cross-check results.

The summons have been issued as “it is aptly clear from the above response that there is no uniformity in ‘Testing Methods’ for the purpose of testing the presence of formaldehyde in baby shampoo and asbestos in talcum powder and the same is clearly a mandate of CDSCO to regulate as per the functions of the CDSCO,” the NCPCR notice said.

Questions over CDSCO regulation

The commission has asked CDSCO to explain why it has not regulated the standards and uniformity in testing methods of accredited laboratories in India. It has also been asked to explain why the testing methods used by the office of the Drug Control Officer in Jaipur to check the presence of formaldehyde and asbestos have not been shared with the commission and whether the testing method is approved by the Indian Pharmacopeia or not.

The commission also asked why proper information has not been provided despite repeated communication.

The commission said that it had informed the CDSCO on 26 February 2020 that the information provided by the body via an affidavit on 23 January 2020 did not respond to the commission’s queries. The NCPCR also said it had pointed out in the summons letter issued on 26 February 2020 that the CDSCO’s functions include “regulation of drugs as well as ‘testing’ of drugs and cosmetics which are either manufactured or imported in India”.

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