CDSCO or Central Drugs Control Organization had published a draft form of guidelines concerning the recall and rapid alert system for cosmetics. It has asked for various suggestions and objections from different industrial stakeholders for submitting responses.

Dr GN Singh, the then DCGI, elaborated that the mission and vision are to protect and increase public health by ensuring the safety, effectiveness and drug quality, cosmetics, and the medical device. To remain in compliance with this, they address the aspects before it is enforced into the act.

A draft guideline was published in 2012 October, and the stakeholders were asked to revert before November 7 2012. After getting all the responses, everything is reviewed accordingly. All the suggestions and objections, when found in the public interest, were forwarded to the Ministry of Health.

A rapid alert system is used for transmitting only those alerts where urgency and seriousness will not permit any delay in the transmission. Assessment should be made of defect seriousness, it's prospective for doing any harm to the patient or the environment.

A recall refers to the action of withdrawing a drug or cosmetic from distribution or use, including any corrective action. Factors promoting a recall action include deficiency in quality, safety, efficacy or any other violation of the laws.

The Drugs & Cosmetics Act, 2020 has laid down provisions to facilitate the responsibility and involvement of cosmetic manufacturers in providing safe and wholesome products to their consumers.

According to the rule 65 of the new act, a step-by-step course of action has been described for the voluntary recall of cosmetics that are deemed to be unsafe or not fit for use by consumers.

If a manufacturer or the authorised agent of a cosmetic has a reason to believe that the manufactured or imported cosmetic is likely to pose any kind of risk to the consumer, he/she shall immediately initiate procedures to withdraw the cosmetic from market circulation.

The manufacturer/authorised agent should also inform the central and state licensing authorities about the matter and co-operate with them to ensure effective and efficient withdrawal of the cosmetic and handle any consequences.

This step taken by the authorities will ensure more active participation of manufacturers in ensuring the safety of cosmetic products. Informing the authorities about these matters on a timely basis shall not attract any serious penalties depending upon the nature of the error.

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