Cosmetics & Personal care Industry in India: Regulatory Aspects & Challenges Sudipta Dey Deputy Drugs Controller(India) CDSCO (HQ)
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION CDSCO The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. Mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices
CDSCO Geographical Location Zonal Offices(6) CDSCO, HQ CDSCO North Zone (Ghaziabad) CDSCO West Zone (Mumbai) CDSCO South Zone (Chennai) CDSCO East Zone (Kolkata) New Delhi CDSCO Zone (Ahmadabad) CDSCO Zone (Hyderabad) Ahmedabad * Mumbai. Kolkata Port Offices/Airports : 13 Laboratories : 7 Sub Zonal Offices (6) Jammu, Bengaluru, Baddi,(Himachal Pradesh) Indore, Goa, Guwahati * Hyderabad Chennai 30 States 6 Union Territories 3
FUNCTIONS Functions of CDSCO Approval of new drugs and clinical trials Import Registration and Licensing of Drugs Licensing of Blood Banks, LVPs, Vaccines, r-dna products & some Medical Devices Amendment to D &C Act and Rules Banning of drugs and cosmetics Grant of Test License, Personal License, NOCs for Export Testing of Drugs Import Registration of Cosmetics
FUNCTIONS Functions of State Authorities Licensing of Manufacturing Site for Drugs including API and Finished Formulation as well as Cosmetics Licensing of Establishment for sale or distribution of Drugs Approval of Drug Testing Laboratories Monitoring of Quality of Drugs and Cosmetics marketed in the country Investigation and prosecution in respect of contravention of legal provision Recall of sub-standard drugs
COSMETICS INDUSTRY AT A GLANCE IN INDIA Indian Cosmetics Market Size of the Industry Exports Domestic Market 7.5 billion USD 1.4 billion USD 6.0 billion USD Annual Growth Rate 10 % Cosmetic products like Soaps, Hair Oil and creams Cover More than 99% of the population, sold through about 7 million shops
What is Cosmetic? Cosmetics are regulated under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. As per Sec 3(aaa) of the said Act, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. 7
Import, Manufacture and Sale of Cosmetics Import- regulated Under and Rules Part XIII of Drugs and Cosmetics Act Manufacture- regulated Under Part XIV of Drugs and Cosmetics Act and Rules Sale and distribution of cosmetics- Exemption given under Schedule K for sale of cosmetic provided the same, if of Indian origin are manufactured by licensed manufacturers. 8
Provisions Schedule M II Schedule Q Limits of heavy metals Requirements of factory premises for manufacture of cosmetics. List of dyes, colours and pigments permitted in cosmetics/soaps as per IS : 4707 (part I)-1988, time to time amended by BIS. Other dyes, colours and pigments not in IS : 4707 (part I) and Schedule Q not permitted. permitted synthetic or natural colours used in cosmetics shall not contain more than:- 2 ppm of Arsenic (calculated as Arsenic Trioxide) 20 ppm of Lead (calculated as Lead) 100 ppm of heavy metals other than Lead (calculated as the total of respective metals) 9
Recent Regulatory changes Regulation of use of mercury compounds in cosmetics Limit of Mercury G.S.R. 56(E) dated 19 th Jan 2017 NMT 70 ppm NMT 1 ppm Cosmetics intended for use in the area of Eye In other finished cosmetics unintentional mercury 10
Provisions Prohibition of manufacture of cosmetics containing hexachlorophene. (Rule 134-A) No cosmetic, prohibited in the country of origin, shall be imported except for the purpose of examination, test or analysis. (Rule 129-F) 11
Labelling, Packing and Standards of cosmetics Rule 146 to Rule 150-A- India specific labelling requirements for cosmetics both manufactured in India or Imported. For imported cosmetics- in addition to the above rules, name and address of the RC holder and RC number (Under Rule 129H). Exemption of batch number or net content in small packs of cosmetics. Standards of Quality of Cosmetics: The cosmetics complies with such standards as may be prescribed Cosmetics included in Schedule S - 36 items of Finished cosmetics so far mentioned to conform BIS specifications (Rule 150A). Imported cosmetics- should comply with Schedule S, Schedule Q or any other standards of quality and safety applicable, and other provisions under the rules (Rule 129G). When imported Cosmetic is not included in Schedule S required to meet with specifications under the rules /standards applicable in the country of origin (Rule 129G). 12
Misbranded, spurious & adulterated cosmetics Misbranded Cosmetics (Sec:17-C): a) contains a color which is not prescribed, b) not labeled in the prescribed manner, c) the label or container or anything accompanying the cosmetic bears any false or misleading statement. Spurious Cosmetics (Sec:17-D): a) Imported in the name of another cosmetic, b) imitation or a substitute of another cosmetic or resembles another cosmetic in a deceiving manner or having name of another cosmetic. c) bears the name of a company that does not exist d) purports to be the product of a manufacturer of whom it is not truly a product. Adulterated Cosmetics (Sec:17-E): a) Contains any filthy, putrid or decomposed substance in whole or part. b) Prepared,packed or stored under insanitary conditions. c) Container composed of any poisonous or deleterious substance. d) Contains any harmful or toxic substance. e) Any substance mixed therewith so as to reduce quality or strength.
Manufacturing and Import Provisions Provisions related to manufacture of Cosmetics The regulatory control over the manufacture of cosmetics - through a system of licensing and inspection by the State Licensing Authorities Provisions related to Import of Cosmetics The regulatory control over imported cosmetics - exercised by the Central Government through system of Registration of Cosmetics by the Central Drugs Standard Control Organization (CDSCO). The mandatory registration for import of Cosmetics have been introduced since April, 2013 14
Prohibition of import of certain cosmetics Any cosmetic which is not of standard quality. Misbranded or spurious cosmetics. not having import registration. containing harmful and unsafe ingredient. whose import is prohibited in India. banned in any country.
CLASSIFICATION OF COSMETIC RAW MATERIALS AND ADJUNCTS AS PER BIS IS 4707 Part 1- Comprising of a positive list of dyes, pigments and colours Part 2- Comprising of a negative list of raw materials a) Generally recognized as safe (GRAS); b) Generally not recognized as safe (GNRAS) Annex- A: List of substances which must not form part of the composition of cosmetic products- eg. Cells, tissues or products of human origin Annex- B: List of substances which cosmetic products must not contain in except subject to restrictions and conditions laid down Annex- C: List of preservatives which cosmetic products may contain Annex- D: List of permitted UV filters which cosmetic products may contain
Recent Regulatory changes Animal Testing Ban: Prohibition testing of cosmetics in the country on animals vide Gazette notification G.S.R. 346 (E) dated May 21, 2014 Prohibition of the import of cosmetics tested on animals vide Gazette notification GSR 718 (E) dated October 13, 2014. Further clarification issued on 15.02.2015 and 29.06.2015 Importer to submit original undertaking from the manufacturer (legal/actual brand owner) of the registered products stating that cosmetic products have not been tested on animals on and after 12.11.2014 New applicants to submit this undertaking along with registration dossier to CDSCO. Copy of the undertaking may be produced at ports for clearing the consignments. 17
Regulatory Challenges: There are 11 categories of cosmetics in Schedule M II & 36 categories in Schedule S. There are new categories of cosmetics like hair styling products, self tanning products, sun protection products, external intimate hygiene products, mouth wash, tooth whitener, face wash, scrubs etc. which are not categorized under present regulation. Interpretation and implementation of rule provisions by different State Licensing Authorities leads to non-uniform practice. Labelling for imported cosmetics is a challenge for complying labelling requirements under Drugs and Cosmetics Rules, 1945 and Legal Metrology and Packaged Commodities Rules 2011. Issue of prohibition of use of plastic microbeads in cosmetics- A writ petition- Mr Ashwini Kumar v/s Union of India & Others under National Green Tribunal- BIS is in the process of adding plastic microbeads (5 mm or less) used in skin exfoliating products in GNRAS list. Prohibition of Triclosan and other harmful chemicals in anti- bacterial soaps & hand sanitizers (prohibited by USFDA)
Misleading label claims on imported and domestically manufactured cosmetics Misleading marketing tendency for cosmetics towards drug like claims such as acne treatment, reduces swelling and redness of skin, inhibiting melanin producing enzyme, clinically proven and prescribed/ recommended by dermatologists/ophthalmologists etc. by manufacturers. USFDA has also seriously taken the issue of drug claim on cosmetic and issued warning letters to some companies. A cosmetic should not have any claim like a topical drug product and the drug domain should not be breached.
Addressing the Regulatory challenges faced by Industry: Some issues of importers/manufacturers are being addressed in the proposed draft Cosmetics Rules, 2017 like- Ease of importing Defining New Cosmetics and its evaluation process with respect to safety and effectiveness. Harmonization with International labeling requirements Perpetuity in manufacturing license etc SUGAM online portal rolled out by CDSCO for ease of business of importers- Developed by CDAC for the implementation of e-governance since 2016 and till date more than 750 permissions have been granted
Thank you Sudipta Dey ddci.dey@gmail.com