The Union health ministry will soon amend Rule 129, 129H, 135A and 145D of the Drugs and Cosmetics Rules, to simplify the provisions relating to registration of cosmetics imported into the country. The Drugs Technical Advisory Board (DTAB), the highest authority under the Union health ministry on technical matters, has recently recommended to the ministry in this regard.
The issue came up for discussion in the DTAB’s 68th meeting held on February 16, 2015. After preliminary discussion, a sub-committee consisting of OS Sadhawani, joint commissioner, FDA, Maharashtra and a representative of the DCGI was constituted to examine the issue and suggest suitable changes in the present rules so that the difficulties of the importers of cosmetics are addressed without compromising the quality and safety of the cosmetics imported into the country.
The sub-committee considered the matter in its meetings held on June 12, 2015. It recommended certain amendments in Rule 129, 129H, 135A and 145D.
On Rule-129 regarding registration of cosmetic products imported into the country, the committee recommended, “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.”
On Rule 129H regarding labeling and packing of cosmetics, it recommended that no cosmetic shall be imported unless it is packed and labelled 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.
On Rule 135A regarding import of cosmetics containing mercury compounds prohibited, the committee recommended, “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.”
On Rule 145D regarding prohibition of manufacture of cosmetics containing mercury compounds, it recommended that 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. On undertaking regarding products not tested on animals, the sub-committee recommended that 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, the committee recommended that free sale certificate issued by National Regulatory Authority or other competent associations/organisations from the country of the legal manufacturer in addition to the actual manufacturer from country of origin can be considered.
For further simplifying the Letter of Authorisation (LoA) in case of third party manufacturing outside India, it recommended that 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.
Simplifying the import of bulk cosmetics and the requirement of a certificate of free sale (CFS), the committee recommended that 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.
The sub-committee further recommended that requirements of Rule 129 for compulsory registration may be kept in abeyance till the above rule is notified.
The DTAB in its 70th meeting held on August 18, 2015 discussed the recommendations of the sub-committee. After deliberations, it agreed to the proposed amendments and the guidelines for simplification of import registration procedures. It recommended for a provision that the cosmetics imported without prior registration shall be subject to test at the time of import. A system of online registration of such import may also be initiated. CDSCO should maintain details of the cosmetics imported in the case of import of cosmetics without registration.