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In Part I of this series, entitled ‘The (Pawsome) Pet Care Sector: Through a Legal Lens’, we supplied a broad introduction of the registration and compliance requirements for entities in the animal care market. We likewise talked about aspects like the entry choices, the sector’s migration to the online mode, and appropriate judicial declarations.
The legal structure for animal care in India is spread out throughout a host of guidelines and legislations. The appropriate regulative responsibilities are likewise divided in between different regulators consisting of the Food and Safety Standards Authority of India (“FSSAI”), the Central Drugs Standard Control Organisation (“CDSCO”), and the Animal Welfare Board of India, to name a few. Therefore, market gamers will need to monitor a vast array of legislations (in addition to appropriate State guidelines and community laws) to make sure correct compliance.
In this 2nd part of the blog site, we will check out and offer a quick introduction of the Indian animal care market, particularly from a pharmaceuticals and health care regulative point of view. This will consist of elements like animal stores, animal food/ nutrition, veterinary drugs, and animal grooming items/ cosmetics.
A. Pet Shops – Further Considerations
As defined 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 suppress the widespread exploitation of animals by ‘pet shop’ owners[2].
Crucially, the Pet Shop Rules offer an inclusive list of ‘pet animals’ like dogs, cats, bunnies, and so on., and clarify that any animal the ownership of, and sell which is not forbidden by any other law, will fall within the scope of the Pet Shop Rules. This need to read with the Wildlife Protection Act, 1972, which supplies an excessive list of animals (under Schedule I and Part II of Schedule II) that might not be had, offered, or kept as family pets. State Governments might change this list with previous approval of the Central Government. Hence, animal shop owners need to take care not to have or offer as family pets, the animals supplied in the said list, and need to monitor appropriate State changes.
Under the Pet Shop Rules, a family pet shop owner need to obtain a Registration Certificate from the Animal Welfare Board of the worried state. Pet shop owners need to think about other appropriate compliances also, consisting of inter alia the commitment to offer sufficient facilities and a long-term structure or building; commitment to offer enough food, tidy drinking water, and tidiness for the animals; commitment to keep apart animals that are hostile to each other; and so on.
B. Pet Food & Nutrition
The pet food sector is presently fragmented and probably doing not have harmony in producing & market practices. Presently, as discussed in Part I of the blog site, there are no obligatory requirements for domestic production of animal food/ nutrition and requirements like the Bureau of Indian Standards (“BIS”) Specification IS 11968:2019 connecting to dog & cat food[3] are voluntary in nature. This leaves scope for market gamers to draw their own requirements, triggering food safety issues and prospective dangers to the health of family pets. However, given that market gamers are still bound by relevant customer defense laws, criminal laws, and the Prevention of Cruelty to Animals Act, 1960 (“PCA”), they need to bear in mind the quality of foods provided for animal usage. Having said that, a legislation/ alert straight resolving quality requirements for animal foods would help offer clearness and reduce the possible regulative dangers.
To this impact, 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 actually looked for to manage imports of particular veterinary drugs, in order to make sure that zoonotic pathogens do not go into the nation. However, couple of issues appear at the beginning – initially, as the title recommends, the 2008 Order just uses to import of animal foodstuff, therefore leaving the domestic sector mostly uncontrolled; and 2nd, the 2008 Order just uses to ‘pet food products of animal origin’, which has actually been specified to imply “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 manage pet foods produced from vegetarian or vegan sources; and (ii) the 2008 Order just controls foodstuff meant for dogs or cats, thus leaving a broad scope of other family pets uncontrolled.
It is notable that the BIS requirements for Compounded Feed for Cattle (IS 2052:2009)[6] have actually been made obligatory by the FSSAI. However, as clarified above, the BIS requirements for animal foods stay voluntary. The method the structure presently exists, it might be said that animal nutrition in India is just controlled to the level that it impacts the health of people. Hence, when the threat is contagious to people (through, for example, usage of meat or milk of livestock/ animals), the food taken in by such animals goes through obligatory requirements. However, when the threat is limited to animals (such as usage of food products by family pets), policy is weak and commonly unenforced. Evidently, there is an upcoming requirement to concentrate on policy of animal food from an animal-protection point of view. Until then, there might be scope for market gamers to make the most of the regulative space by preventing compliances, licence procurements, or safety & screening requirements, while potentially prejudicing the health of animal animals.
That said, market gamers need to bear in mind distinctions in State guidelines. For circumstances, some States in India allow the sale and usage of dog meat. While normally thought about ‘pets’, dogs in these States are taken in as meat, thus raising some doubts regarding which BIS requirements would apply for their feed. This is particularly because of the recent order gone by the Gauhati High Court, where the court quashed the restriction on sale and usage of dog meat in Nagaland[7]. Nonetheless, market gamers in these States will need to abide by inter alia the PCA and the Prevention of Cruelty to Animals (Slaughter House) Rules, 2001[8] in addition to appropriate State and community laws.
To deal with the regulative spaces, it is possible to draw motivation from the Food Safety Modernization Act, 2011 (“FSMA”) enacted in the United States of America (“USA”)[9]. The FSMA puts down requirements for both human food and food for animals, consisting of family pets. Some helpful functions of the FSMA’s policy of animal food consist of – compliance with Current Good Manufacturing Practices; compliance with the Preventive Controls for Animal Food (“PCAF”) Rule consisting of elements like basic sanitation requirements, risk analysis, and preventive controls food safety strategy, to name a few; appointment of a Preventive Controls Qualified Individual; adoption of a supply chain program, recall strategy, tracking and application treatments; and so on.
Given the regulative space, the FSMA and PCAF Rule might offer some assistance for Indian regulators to start efficient policy of animal food and nutrition.
C. Veterinary Drugs
The Drugs & Cosmetics Act, 1940 (“D&C Act”) specifies ‘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 meaning consists of medications meant for usage of animals, veterinary drugs are directly covered within the scope of the D&C Act. Hence, any entity which plans to produce, offer, stock, display or market, or disperse by retail or wholesale any veterinary drugs will need to abide by the licensure and regulative requirements set out in the D&C Act check out with the Drugs Rules, 1945 (“Drugs Rules”). This would consist of not simply drug stores, however any veterinary center or healthcare facility took part in the sale, equipping, showing for sale, and so on., of veterinary drugs[10].
Given the parity in policy of drugs meant for people and for animals, other guidelines relating to ‘drugs’ will use to animal health/ pet care market gamers also. 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 policy of pet grooming products in India. It suggests that products meant 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 guidelines – an area which presently has actually large scope to be reinforced in India.
