The evaluation of product claims cannot be separated from the consideration of whether a product is a cosmetic or not. Whether a product can be considered to be a cosmetic product depends on several factors, claims are an important element of this process.
This guideline provides a simple 5-step decision-making process that helps to identify products and claims which can be considered to be cosmetics. The document also provides some examples of unacceptable claims for cosmetic products. However, it is not to be taken as the final authority nor as an exhaustive list.

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The guideline requires the CNH to keep a product information file “readily accessible to the NPRA at the address specified on the label”.The main objective of this guideline is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits.

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A manufacturer holding valid license copy in Form -25 and Form- 28 can obtain No Objection Certificate from Zonal/Sub Zonal offices of Central Drugs Standard Control Organisation (CDSCO) for export purposes only for approved / unapproved new drug / banned drug in India.

The following documents are required for the issuance of the No Objection Certificate for the export of drugs from India.

  1. Covering letter
  2. Purchase order
  3. Manufacturing License
  4. Performa invoice
  5. Registration certificate
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This article describes the list of equivalent cosmetic GMP guidelines.

  • Good Manufacturing Practices for Pharmaceutical Products, World Health Organisation (WHO)
  • Australian Code of Good Manufacturing Practice for Therapeutic Goods Sunscreen Products, Therapeutic Goods Administration (TGA)
  • ISO Standard 22716: Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices
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The guideline has been produced to offer assistance to the cosmetic industry in compliance with the requirements for Cosmetic GMP. As this document is particularly intended for cosmetic products, clear delineation from drug or pharmaceutical product.

This guideline serves as a general guide for the manufacturers to develop their internal quality management system and procedures. The important objective must be met in any case, i.e. the final products must meet the quality standards appropriate to their intended use to assure consumer’s health and benefit.

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The schedule Y of the Drugs and Cosmetic Act (DCA) and Rules there under specify requirements for clinical trials and market authorization.

The reviews of applications for granting authorization to conduct clinical trials or to market a new drug in the country, require a multidisciplinary assessment by regulatory authorities (RAs) and scientific experts, to ensure that the applications meet the necessary regulatory standards and scientific evidence for safety, efficacy and quality.

Good review practices assist the RAs to achieve timely and quality review. A complete application is a prerequisite to ensure an efficient review process.

There are four types of applications for submissions:

  1. Investigational new drugs clinical trials
  2. New drug clinical trials
  3. Global clinical trials
  4. Post marketing studies
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Advertisements include any notice, circular, report, commentary, pamphlet, label, wrapper or other documents, and any announcement made orally or by any means of producing or transmitting light or sound.

“advertisement” means every form of advertising (whether or not accompanied by or in association with spoken or written words or other writing or sounds and whether or not contained or issued in a publication) by the display of notices or by means of catalogues, price lists, circulars, labels, cards or other documents or materials or by the exhibition of films or of pictures of photographs, or by means of radio or televisions, or in any other way including through electronic means. “Electronic” means the technology of utilizing the electrical, optical, magnetic, electromagnetic, biometric, photonic or other similar technology.

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