 regulates Quality, Safety and efficacy of New Drugs including vaccines as per the provision of New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.){kind=link}
The Central Drugs Standard Control Organization (CDSCO) has filed an affidavit in the Delhi High Court in a plea seeking the labeling of products, including food items and cosmetics vegetarian or non-vegetarian, not only on the basis of its ingredients but also on the substance used in the manufacturing process.
According to the affidavit, a similar matter has been dealt with by the Supreme Court in the matter of Union of India and Others Versus Ozair Husain, wherein the said appeal has been preferred by the appellants against the judgment dated November 13, 2002 passed by the Division Bench of the Delhi High Court in a Public Interest Litigation whereby the High Court held that the consumer has the fundamental right to know whether the food products, cosmetics and drugs available for human consumption are of non-vegetarian or vegetarian origin. The Supreme Court decided the said appeal on 07.03.2013 (reportable) which held as under :-
“29. In view of the discussions above , we hold that the High Court under Article 226 of the Constitution of India has no jurisdiction to direct the Executive to exercise power by way of subordinate Legislation pursuant to power delegated by the Legislature to enact a law in a particular manner, as has been done in the present case. For the same reason, it was also not open to the High Court to suggest any interim arrangement as has been given by the impugned judgment. The writ petition filed by Respondent being not maintainable for issuance of such direction, the High Court ought to have dismissed the writ petition in limine.”
The CDSCO regulates Quality, Safety and efficacy of New Drugs including vaccines as per the provision of New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.
It was submitted by the CDSCO that the issue was put up for its deliberation in the 86th Drugs Technical Advisory Board (DTAB) meeting held on 13.04.2021. After detailed deliberation, the Board emphasized that there is no clarity and system to certify vegetarian and non-vegetarian ingredients in the country.
Therefore, the CDSCO said that the Board did not agree for mandating the indication of green or red /brown dots on every package of cosmetics, as it may complicate the regulation and add regulatory burden on stakeholders.
“However, the Board opined that, it can be voluntary and left to the company’s own decision for labeling red/brown or green dots on packages of soaps, shampoos, toothpastes and other cosmetics and toiletries for non-vegetarian or vegetarian origin. In view of above, it is advised that the manufacturers of cosmetics may indicate red/brown or green dot on packages of soaps, shampoos, toothpastes and other cosmetics and toiletries on voluntary basis for its non-vegetarian or vegetarian origin respectively,” the affidavit reads.
It is further stated that accordingly, CDSCO has issued an advisory notice vide dated 10.09.2021 stating “manufacturers of cosmetics may indicate red/brown or green dot on package of soaps, shampoos, toothpastes and other cosmetics and toiletries on voluntary basis for its non vegetarian or vegetarian origin respectively.”
It is pertinent to note that Delhi High Court on December 9, taking note of the plea filed by Ram Gau Raksha Dal through advocate Rajat Aneja had made it mandatory for all food business operators to make a full and complete disclosure of all the ingredients that go into the making of any food item.
Matter will be put up on January 31 for further hearing.