Drugs and Cosmetics Rules Will Be Amended to Simplify Registration Procedures for Cosmetics in India

Cosmetics importers in India have been demanding that the provisions relating to registration of cosmetics be simplified for quite some time. In response the health ministry then asked the Drug Technical Advisory Board (DTAB) to examine the issue.

DTAB started to discuss this issue in its 68th meeting held on February 16, 2015. After a preliminary discussion, a sub-committee consisting of OS Sadhawani, joint commissioner, FDA Maharashtra and a representative of the Drug Controller General of India (DCGI) was established to examine the issue and suggest suitable changes in the present rules.

The committee recommended certain amendments in Rule 129, 129H, 135A and 145D of the Drugs and Cosmetics Rules.

Rules	Current version	Recommended version
Rule 129 Registration of cosmetic products imported into the country	No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.	No cosmetic shall be imported into India unless the product is registered under the Rules by the licensing authority appointed by the Central government under Rule 21 or by any person to whom such powers may be delegated under Rule 22 or unless otherwise the products are complying with the standards specified in Drugs and Cosmetics Rules, 1945.
Rule 129H Labeling and Packing of Cosmetics	No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Parts XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India.	No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Part XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India or in case the products are not registered, the importer shall give undertaking at the port entry that products are manufactured by the manufacturer stated on the label.
Rule 135A Import of cosmetics containing mercury compounds prohibited	No cosmetic shall be imported which contains mercury compounds.	No cosmetic shall be imported which contains mercury compounds. Provided the presence of traces of unintentional mercury should not exceed 1 parts per million (ppm) in finished cosmetics. Provided further that for those cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0.0065 per cent) of mercury, calculated as the metal, as a preservative.
Rule 145D Prohibition of manufacture of cosmetic containing mercury compounds	No cosmetic containing Mercury compounds shall be manufactured.	No cosmetic containing mercury compounds shall be manufactured. Provided the presence of traces of unintentional mercury should not exceed 1 parts per million (ppm) in finished cosmetics. Provided further that for those cosmetics intended for use only in the area of the eye, level of mercury should not exceed more than 65 parts per million (0.0065 per cent) of mercury, calculated as the metal, as a preservative.

The committee also recommended for simplification of the import registration procedures.

Topics	Simplification
Undertaking regarding products not tested on animals	The manufacturer either legal or actual /brand owner of the products/Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after November 12, 2014 along with import registration dossiers to CDSCO. The acknowledgment copy for submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in future for clearing their future consignments.
Simplifying the free sale certificate from the responsible person instead of the actual manufacturer	Free sale certificate issued by National Regulatory Authority or other competent associations/organizations from the country of the legal manufacturer in addition to the actual manufacturer from country of origin can be considered.
Further simplifying the Letter of Authorization (LoA) in case of third party manufacturing outside India	In the cases where the brand owner is located in India and gets its products manufactured from sites located outside India a LoA can be considered in place of power of attorney (PoA). The overseas manufacturer has to give acceptance of LoA and conditions on appostilled copy. (In India, appostilled documents are authenticated by the state authorities. It need not be notarized or attested once its appostilled.)
Simplifying the import of bulk cosmetics and the requirement of a certificate of free sale (CFS)	The applicants can obtain FSC either from the country of origin or any other major market where the same product is freely sold. Alternatively bulk importers could get the bulk cosmetics tested in India at a government laboratory to obtain custom clearance.

On August 18, 2015, the DTAB discussed the recommendations of the sub-committee in its 70th meeting. After deliberation, it agreed to the proposed amendments and the guidelines for simplification of import registration procedures. Cosmetics imported without prior registration shall be subject to testing at the time of import. An online registration system for imported products may also be implemented in the future.

* Reference Link: Health ministry to amend D&C Rules to simplify import registration procedures for cosmetics