In Part I of this series, titled ‘The (Pawsome) Pet Care Sector: Through a Legal Lens’, we provided a broad overview of the registration and compliance requirements for entities in the pet care industry. We also discussed factors like the entry options, the sector’s migration to the online mode, and relevant judicial pronouncements.
The legal framework for pet care in India is spread across a host of rules and legislations. The relevant regulatory duties are also divided between various regulators including the Food and Safety Standards Authority of India (“FSSAI”), the Central Drugs Standard Control Organisation (“CDSCO”), and the Animal Welfare Board of India, among others. Therefore, industry players will have to keep track of a wide range of legislations (along with relevant State rules and municipal laws) to ensure proper compliance.
In this second part of the blog, we will explore and provide a brief overview of the Indian pet care industry, specifically from a pharmaceuticals and healthcare regulatory perspective. This will include aspects like pet shops, pet food/ nutrition, veterinary drugs, and pet grooming products/ cosmetics.
A. Pet Shops – Further Considerations
As specified in Part I of this series, the Ministry of Environment, Forest and Climate Change, enacted the Prevention of Cruelty to Animals (Pet Shop) Rules, 2018[1] (“Pet Shop Rules”) to curb the rampant exploitation of animals by ‘pet shop’ owners[2].
Crucially, the Pet Shop Rules provide an inclusive list of ‘pet animals’ like dogs, cats, rabbits, etc., and clarify that any animal the ownership of, and trade in which is not prohibited by any other law, will fall within the scope of the Pet Shop Rules. This must be read with the Wildlife Protection Act, 1972, which provides a prohibitive list of animals (under Schedule I and Part II of Schedule II) that may not be possessed, sold, or kept as pets. State Governments may amend this list with prior approval of the Central Government. Hence, pet shop owners must be careful not to possess or sell as pets, the animals provided in the said list, and must keep track of relevant State amendments.
Under the Pet Shop Rules, a pet shop owner must obtain a Registration Certificate from the Animal Welfare Board of the concerned state. Pet shop owners must consider other relevant compliances as well, including inter alia the obligation to provide adequate amenities and a permanent structure or building; obligation to provide sufficient food, clean drinking water, and cleanliness for the animals; obligation to keep apart animals that are inimical to each other; etc.
B. Pet Food & Nutrition
The pet food sector is currently fragmented and arguably lacking uniformity in manufacturing & industry practices. Presently, as mentioned in Part I of the blog, there are no mandatory standards for domestic production of pet food/ nutrition and standards like the Bureau of Indian Standards (“BIS”) Specification IS 11968:2019 relating to dog & cat food[3] are voluntary in nature. This leaves scope for industry players to draw their own standards, causing food safety concerns and potential risks to the health of pets. However, since industry players are still bound by applicable consumer protection laws, criminal laws, and the Prevention of Cruelty to Animals Act, 1960 (“PCA”), they must be mindful of the quality of foods offered for pet consumption. Having said that, a legislation/ notification directly addressing quality standards for pet foods would help provide clarity and minimise the possible regulatory risks.
To this effect, the Department of Animal Husbandry, Dairying and Fisheries, enacted the Pet Food Products of Animal Origin (Import into India) Order, 2008 (“2008 Order”)[4]. Specifically, the 2008 Order has sought to control imports of certain veterinary drugs, in order to ensure that zoonotic pathogens do not enter the country. However, few problems appear at the outset – first, as the title suggests, the 2008 Order only applies to import of pet food products, thus leaving the domestic sector largely unregulated; and second, the 2008 Order only applies to ‘pet food products of animal origin’, which has been defined to mean “Dried Processed pet food containing the ingredients of meat and meat products from avian species, pig and product of animal origin intended for use in animal feeding or other kinds of edible ingredient from animal origin from nutritional point of view used for feeding the dog or cat”[5]. Thus, it is clear that (i) the 2008 Order does not regulate pet foods produced from vegetarian or vegan sources; and (ii) the 2008 Order only regulates food products intended for dogs or cats, hence leaving a wide scope of other pets unregulated.
It is noteworthy that the BIS standards for Compounded Feed for Cattle (IS 2052:2009)[6] have been made mandatory by the FSSAI. However, as clarified above, the BIS standards for pet foods remain voluntary. The way the framework currently exists, it could be said that animal nutrition in India is only regulated to the extent that it affects the health of human beings. Hence, when the risk is communicable to human beings (through, for instance, consumption of meat or milk of cattle/ livestock), the food consumed by such animals is subject to mandatory standards. However, when the risk is restricted to animals (such as consumption of food items by pets), regulation is weak and widely unenforced. Evidently, there is an impending need to focus on regulation of pet food from an animal-protection perspective. Until then, there may be scope for industry players to take advantage of the regulatory gap by avoiding compliances, licence procurements, or safety & testing standards, while possibly prejudicing the health of pet animals.
That said, industry players must be mindful of differences in State rules. For instance, some States in India permit the sale and consumption of dog meat. While generally considered ‘pets’, dogs in these States are consumed as meat, hence raising some doubts as to which BIS standards would be applicable for their feed. This is especially in light of the recent order passed by the Gauhati High Court, wherein the court quashed the ban on sale and consumption of dog meat in Nagaland[7]. Nonetheless, market players in these States will have to comply with inter alia the PCA and the Prevention of Cruelty to Animals (Slaughter House) Rules, 2001[8] along with relevant State and municipal laws.
To address the regulatory gaps, it is possible to draw inspiration from the Food Safety Modernization Act, 2011 (“FSMA”) enacted in the United States of America (“USA”)[9]. The FSMA lays down standards for both human food and food for animals, including pets. Some useful features of the FSMA’s regulation of pet food include – compliance with Current Good Manufacturing Practices; compliance with the Preventive Controls for Animal Food (“PCAF”) Rule including aspects like basic sanitation standards, hazard analysis, and preventive controls food safety plan, among others; appointment of a Preventive Controls Qualified Individual; adoption of a supply chain program, recall plan, monitoring and implementation procedures; etc.
Given the regulatory gap, the FSMA and PCAF Rule may provide some guidance for Indian regulators to initiate effective regulation of pet food and nutrition.
C. Veterinary Drugs
The Drugs & Cosmetics Act, 1940 (“D&C Act”) defines ‘drug’ as “all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals…” Since the definition includes medicines intended for use of animals, veterinary drugs are squarely covered within the scope of the D&C Act. Hence, any entity which intends to manufacture, sell, stock, exhibit or offer for sale, or distribute by retail or wholesale any veterinary drugs will have to comply with the licensure and regulatory requirements laid out in the D&C Act read with the Drugs Rules, 1945 (“Drugs Rules”). This would include not just pharmacies, but any veterinary clinic or hospital engaged in the sale, stocking, exhibiting for sale, etc., of veterinary drugs[10].
Given the parity in regulation of drugs intended for human beings and for animals, other regulations pertaining to ‘drugs’ will apply to animal health/ pet care industry players as well. For instance, an entity which does not have manufacturing arrangements in place but plans to use the manufacturing facilities used by another licensee, may have to apply for a loan licence[11]. Further, an entity wishing to outsource manufacturing of the veterinary drug but sell/ market the same under its own brand name, may fall within the scope of the Gazette Notification no. GSR 101(E) dated February 11, 2020[12]. Under the said notification, a ‘marketer’[13] has been made jointly responsible along with the manufacturer, for quality and other compliances.
Moreover, the D&C Act currently lacks provisions to regulate online sale of drugs. While a draft amendment to the D&C Rules was published in 2018[14], these have not yet been finalised. As of now, the Delhi High Court has prohibited online sale of medicines[15]. A similar prohibition was imposed by the Madras High Court[16], however, a division bench of the Madras High Court subsequently stayed the ban on online sale of medicines[17]. It appears that veterinary drugs would be held to the same standard, thus raising questions on the risks and permissibility of online sale of such drugs.
Additionally, manufacturers and marketers of veterinary biologicals must consider the implications of the ‘Guidance for Industry Document for Veterinary Biologicals in India’ released by the CDSCO[18]. Through this document, the CDSCO has sought to regulate the import or manufacture, registration and marketing approval of new drugs including new biological entities, new indications, new dosage forms, modified release forms, new routes of administration etc. under the D&C Act and Drugs Rules, specifically for veterinary biologicals[19].
Industry players will have to be mindful of all such compliance requirements when engaging or dealing in veterinary drugs or biologicals.
D. Pet Grooming Products/ Cosmetics
Unlike the case with ‘drugs’, the definition of ‘cosmetic’ under the D&C Act is restricted to the human body and excludes any reference to animals. This raises doubts regarding the regulation of pet grooming products in India. It suggests that products intended for cleansing, beautifying, or promoting attractiveness of the pet animal (for example, dog shampoos), may not be subject to the standards laid out in the D&C Act read with the Cosmetics Rules, 2020 (“Cosmetics Rules”). This leads to a potential lacuna in regulation, as the safety and testing compliances for cosmetics, standards for ‘new cosmetics’, as well as prohibitive rules (such as prohibition of testing on animals) under the Cosmetics Rules, may not be applicable to pet grooming products.
However, industry players will have to be careful when categorising such products as cosmetics. If the product in question claims to perform any therapeutic function over and above mere beautification/ cleansing of the pet, then regulators may construe the same as a ‘drug’. For instance, a dog shampoo which claims to prevent anaemia or illness caused by fleas or ticks, would likely qualify as a ‘drug’ rather than ‘cosmetic’. In such a situation, the product will have to comply with the regulatory and licensure requirements laid out in the Drugs Rules, and the market player will be subject to the penalties in the D&C Act read with the Drugs Rules for non-procurement of the relevant licence.
A similar position exists in the USA, where the Food and Drug Administration (“FDA”) has clarified that since the statute (21 U.S. Code § 321) defines ‘cosmetic’ as pertaining only to human use, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control[20]. However, if such products are intended for any therapeutic purpose or to affect the structure or function of animals, they are subject to regulation as ‘new animal drugs’ under the statute[21].
Therefore, greater clarity is required on the regulation of pet grooming products/ pet cosmetics in India. Until then, industry players must be mindful that while a gap may exist for such products under the D&C Act read with the Cosmetics Rules, they must still comply with relevant labelling and packaging laws, consumer protection laws, animal cruelty and criminal laws, etc.
E. Concluding Remarks
The pharmaceutical and healthcare regulatory framework for the Indian pet care sector is spread across several legislations and governed by various regulators. Industry players will have to be mindful not only of Central legislations but also of State rules & amendments, and relevant municipal laws depending on the area of operation. There is a need for legislative clarity on regulation of inter alia pet nutrition and pet grooming products, and until then, industry players will have to tread carefully while complying with all other applicable laws. Given the multiplicity of regulators, it may be useful to consider establishing one nodal authority to govern all aspects of pet care regulation, ranging from drugs, cosmetics and food, to setting up of pet shops and veterinary clinics. Doing so would also help with effective and uniform enforcement of pet care regulations – an area which presently has wide scope to be strengthened in India.
For further information, please contact:
Sreetama Senr, Partner, Cyril Amarchand Mangaldas
sreetama.sen@cyrilshroff.com
[1] Ministry of Environment, Forest and Climate Change, Notification No. G.S.R. 844(E), dated September 6, 2018, available at https://www.awbi.in/awbi-pdf/Pet%20Shop%20Rules%202018%20-%2027%206%202019%20English.pdf, (last accessed June 27, 2023).
[2] As provided in Part I of this blog, under rule 2(1)(k) of the Pet Shop Rules, a “pet shop” includes any shop, place or premises where pet animals are sold, housed, kept or exhibited for sale/ wholesale, and includes online platforms where purchase and sale of pet animals takes place.
[3] Bureau of Indian Standards, IS 11968:2019, available at https://www.services.bis.gov.in/php/BIS_2.0/bisconnect/standard_review/Standard_review/Isdetails?ID=MzE4OQ%3D%3D, (last accessed June 27, 2023).
[4] Ministry of Agriculture, Pet Food Products of Animal Origin (Import into India) Order, 2008, Notification No. S.O. 1086(E) dated May 2, 2008, available at https://aqcsindia.gov.in/pdf/trade-17.pdf, (last accessed June 27, 2023).
[5] Defined under section 2(g) of the 2008 Order.
[6] Bureau of Indian Standards, IS 2052:2009 dated June, 2009, available at https://law.resource.org/pub/in/bis/S06/is.2052.2009.pdf, (last accessed June 27, 2023).
[7] Neizevolie Kuotsu alias Toni Kuotsu & Ors. v. State of Nagaland & Ors., WP(C)/128/2020, Judgement dated June 2, 2023.
[8] Government of India, Prevention of Cruelty to Animals (Slaughter House) Rules, 2001, available at https://www.awbi.in/awbi-pdf/(SLAUGHTER%20HOUSE)%20RULES,%202001.pdf, (last accessed June 27, 2023).
[9] US FDA, Food Safety Modernization Act, 2011, available at https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma, (last accessed June 27, 2023).
[10] This includes, as the case may be, a license in Form 20 to sell, stock or exhibit or offer for sale, or distribute by retail, drugs other than those specified in Schedules C, C(I) and X; license in Form 25 to manufacture for sale or for distribution of drugs other than those specified in Schedules C, C(1) and X; etc.
[11] Under Form 25A, Form 27A, or Form 28A, as the case may be.
[12] Ministry of Health and Family Welfare, Notification No. GSR 101(E), dated February 11, 2020, available at https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU1OA==, (last accessed June 27, 2023).
[13] Under the Notification, “marketer” is defined as “a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution”.
[14] Ministry of Health and Family Welfare, Notification No. GSR 817(E), dated August 28, 2018, available at https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkzOQ==, (last accessed June 27, 2023).
[15] Dr. Zaheer Ahmed v. Union of India & Ors., W.P.(C) 11711/2018, Order dated December 12, 2018.
[16] Tamil Nadu Chemists & Druggists Association v. Union of India & Ors.,W.P. No. 28716 of 2018, Order dated December 17, 2018.
[17] Tamil Nadu Chemists & Druggists Association v. Union of India & Ors, CMP No. 23341 of 2018, Order dated January 2, 2019.
[18] CDSCO, ‘Guidance for Industry Document for Veterinary Biologicals in India’, available at https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadReportsFiles/docVeterinaryBiological.pdf, (last accessed June 27, 2023).
[19] “Veterinary biologicals” have been defined under the Guidance, as “vaccines, serums, etc., prepared for creating active or passive immunity, measuring the state of immunity or diagnosing a disease or health disorder in animals”.
[20] US FDA, ‘Animal Products FDA Regulates’, available at https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates#Grooming, (last accessed June 27, 2023).
[21] Id.
