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2024 (7) TMI 1237

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..... or misrepresentation of facts, shall render such ruling to be void ab initio in accordance with Section 104 of the Act. 5. The provisions of both the Central Goods and Services Tax Act and the Tamil Nadu Goods and Services Tax Act (herein referred to as an Act) are the same except for certain provisions. Therefore, unless a mention is specifically made to such dissimilar provisions, a reference to the Central Goods and Services Tax Act would also mean a reference to the same provisions under the Tamil Nadu Goods and Services Tax Act. M/s. International Institute of Bio Technology and Toxicology, No. 3/266, BDO Office Road, Padappai, Kancheepuram, Tamilnadu-601301, (hereinafter called as 'the Applicant') is a Society registered under the Tamil Nadu Societies Registration Act, 1975 (Act No. 27 of 1975) bearing Registration No. 313 of 1985. They are registered under the GST Acts with GSTIN: 33AAATF0061E1ZG. They have preferred an application seeking Advance Ruling on the following: "Whether Notification No. 04/2019 - Integrated Tax, issued dated 30th September 2019, shall be applicable on the services supplied by the applicant, i.e., research and development services provided in .....

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..... rop protection and Management). Testing of Transport Packaging Materials for chemicals, Pharmaceuticals, Food and Feed additives. Provision of Independent inspections, Quality control and Quality assurance services. 6. In the year 1999, the Applicant had decided to implement the globally accepted standards (i.e.) Good Laboratory Practices (GLP) as per Organization for Economic Co-Operation and Development (OECD) Principles of GLP. The Applicant had engaged various international experts / consultants / scientists to transfer the Good Laboratory Practices (GLP) technology to the Applicant, to train the staff/scientists adequately and upgrade the facilities to the satisfaction and compliance to the OECD GLP standards /principles. 7. Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food .....

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..... nt and also the registration of molecules, both pharmaceuticals and agrochemicals. These include crop residue studies, Drug metabolism and pharmacokinetics processed fractions, environmental fate, Stability Studies, ecotoxicology, plant/soil metabolism, product chemistry, Bioequivalence studies, Bio-availability studies, Bio analytical studies and exposure studies using state of the art instrumentation. IIBAT specializes in analytical services for studies, equipped with well trained and experienced personnel; and top-end analytical equipment like, high-end LC-MS/MS, GC-MS/MS, ICP-MS, etc. 2. Bio-efficacy IIBAT offers a variety of research and development of scalable integrated and comprehensive evaluations by critical and accurate assessments of pathology endpoints to give accurate, reproducible findings and concise, responsive interpretation and consultation. In agrochemical, bio-efficacy is a measure of the biological efficacy of an active ingredient of agrochemicals such as insecticide etc. 3 Genetic Toxilogy IIBAT specializes in this integral component of toxicity evaluation as per regulatory services globally. For identifying the genotoxicity potential of compound .....

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..... nt receives the consideration in convertible foreign exchange for providing these services to sponsors outside India. Further, the place of effective use and enjoyment of the above' services is purely in the hands of service recipient who is located outside India. 5.3. The applicant would like to draw reference to Notification No. 04/2019 dated 30 September 2019, issued under Section 13 (13) of the IGST Act, 2017. It states that place of supply for specific list of services related to pharmaceutical sector shall be the location of the recipient of services subject to fulfilment of the following conditions: a. Supply of services from the taxable territory are provided as per a contract between the service provider located in taxable territory and service recipient located in non-taxable territory. b. Such supply of services fulfils all other conditions in the definition of export of services, except sub-clause (iii) provided at clause (6) of Section 2 of Integrated Goods and Services Tax Act, 2017 5.4. The applicant stated that they fulfil the conditions as stated in the above notification with respect to the supply of services made outside India and all the services provided .....

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..... activities or transactions constitute a supply in accordance with the provisions of sub-section (1), they shall be treated either as supply of goods or supply of services as referred to in Schedule II. (2) Notwithstanding anything contained in sub-section (1),- (a) activities or transactions specified in Schedule III; or (b) such activities or transactions undertaken by the Central Government, a State Government or any local authority in which they are engaged as public authorities, as may be notified by the Government on the recommendations of the Council, shall be treated neither as a supply of goods nor a supply of services. (3) Subject to the provisions of 6[sub-sections (1), (1A) and (2)], the Government may, on the recommendations of the Council, specify, by notification, the transactions that are to be treated as - (a) a supply of goods and not as a supply of services; or (b) a supply of services and not as a supply of goods." 6.3. Section 9 of the CGST Act provides for the levy and collection of GST. Relevant extract of the same has been extracted as follows:- "9. (1) Subject to the provisions of sub-section (2), there shall be levied a tax called the Central .....

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..... r services or both to a Special Economic Zone developer or a Special Economic Zone unit. 6.8. Section 13 of the IGST Act describes the provision for place of supply of services where location of supplier or location of recipient is outside India. Section 13 (3) of the IGST Act, 2017 states that "The place of supply of the following services shall be the location where the services are actually performed, namely: - a. services supplied in respect of goods which are required to be made physically available by the recipient of services to the supplier of services, or to a person acting on behalf of the supplier of services in order to provide the services: Provided that when such services are provided, from a remote location by way of electronic means, the place of supply shall be the location where goods are situated at the time of supply of services: Provided further that nothing contained in this clause shall apply in the case of services supplied in respect of goods which are temporarily imported into India for repairs or for any other treatment or process and are exported after such repairs or treatment or process without being put to any use in India, other than that .....

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..... ion of Supply (1) (2) (3) 1 Integrated discovery and development This process involves discovery and development of molecules by pharmaceutical sector for medicinal use. The steps include designing of compound, evaluation of the drug metabolism, biological activity, manufacture of target compounds, stability study and long-term toxicology impact. 2. Integrated Development 3 Evaluation of the efficacy of new chemical/ biological entities in animal models of disease This is in vivo research (i.e., within the animal) and involves development of customized animal model diseases and administration of novel chemical in doses to animals to evaluate the gene and protein expression in response to disease. In nutshell, this process tries to discover if a novel chemical entity that can reduce or modify the severity of diseases. The novel chemical is supplied by the service recipient located in non-taxable territory. 4. Evaluation of biological activity of novel chemical/ biological entities in in- vitro assays This is in vitro research (i.e., outside the animal). Am assayis first developed and then the novel chemical is supplied by the service recipient located in non-taxab .....

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..... of services. Relevant extracts of the same are reproduced below: "The explanatory notes of the scheme of classification of service indicate the scope and coverage of the heading, groups and service codes of the Scheme of Classification of Services. These may be used by the assessee and the tax administration as a guiding tool for classification of services. However, it may be noted that where a service is capable of differential treatment for any purpose based on its description, the most specific description shall be preferred over a more general description. SAC Code as per the Explanatory notes: 9981 - Research and development services 99811 - Research and experimental development services in natural sciences and engineering 998113 Research and experimental development services in medical sciences and pharmacy 'This service code includes basic and applied research services and experimental development services related to treatment of diseases, preventive hygiene, pharmacy, etc." 998114 - Research and experimental development services in agricultural sciences "This service code includes basic and applied research services and experimental development services rela .....

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..... s in India, i.e., the taxable territory. In such case, place of supply shall be deemed to be the location where the services are actually performed. 7.6. However, reference also needs to be made to section 13 (13) of the IGST Act with regard to the services rendered by the Applicant to the sponsors outside India. The intention of this provision was to avoid double taxation of services in cases where the place of effective use and enjoyment was outside India. The Government may notify any description of services or circumstances under section 13 (13) of the IGST Act, wherein the place of supply shall be the place of effective use and enjoyment of a service. 7.7. Notification no. 04/2019-Integrated Tax dated 30th September 2019 was provided to notify the list of services for which the place of supply of service shall be the place of effective use and enjoyment of the service subject to certain conditions and as per the aforesaid notification, place of supply for the Supply of research and development services related to pharmaceutical sector as specified in Column (2) and (3) from SI. No. 1 to 10 of Table B by a person located in taxable territory to a person located in the non-tax .....

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..... equipped with well trained and experienced personnel; and top-end analytical equipment like, high-end LC-MS/MS, GC-MS/MS, ICP-MS, etc. SI. No. 1-Integrated discovery and development SI. No. 2-Integrated Development SI. No. 5-Drug metabolism and pharmacokinetics of new chemical entities SI. No. 07-Stability studies SI. No. 08-Bioequivalence and Bioavailability studies SI. No. 10 - Bio analytical studies 2. Bio-efficacy IIBAT offers a variety of research and development of scalable integrated and comprehensive evaluations by critical and accurate assessments of pathology endpoints to give accurate, reproducible findings and concise, responsive interpretation and consultation. In agrochemical, bio-efficacy is a measure of the biological efficacy of an active ingredient of agrochemicals such as insecticide etc. SI. No. 1-Integrated discovery and development SI. No. 2-Integrated Development SI. No. 3-Evaluation of the efficacy of new chemical/biological entities in animal models of disease 3. Genetic Toxilogy  IIBAT specializes in this integral component of toxicity evaluation as per regulatory services globally. For identifying the genotoxicity potential o .....

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..... where the request for clarification on GST related to export of services in the pharmaceutical sector was considered. It was brought to notice of the council that the pharma sector in India is made to pay GST of 18% on services given to foreign clients due to lack of clarity on place of supply of pharma R&D Services. Indian pharma companies were losing competitiveness as pharma R&D services given to foreign clients were not treated as exports. This had led to loss in export contracts as service providers in other countries were more cost effective. Due to this, the Government was also losing export revenue amounting to Rs. 170 Crores per year. 8.2. The relevant extracts of the minutes of the meeting with respect to this issue are provided below for reference,- "4. In pharma R&D services, client provides reference materials, sample drugs, reagent etc. All these R&D services are administered on the materials supplied at the laboratory of the pharmaceutical industry. Further it is to say that, such materials supplied by the client gets consumed in the process. 5. It is important to determine whether service provided fall within the meaning of "goods that are made physically avai .....

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..... such sample molecules as goods, as per the Education Guide of Service Tax, provision of a market research service to a manufacturing firm for a consumer product (say, a new detergent) will not fall in the category of Section 13 (3) (a) of IGST Act, even if the market research firm is given say, 1000 nos. of 1 kilogram packets of the product by the manufacturer, to carry for door-to-door surveys. 8. Prima facie, few samples given by foreign clients to Indian pharma do not make place of supply of specific R&D services as location of service provider as per Section 13 (3) (a) of IGST Act and hence such specific services rendered by Indian pharma qualify as 'export of services' 9. On 27.04.2018, the Finance Secretary observed in the file F.No. 345/58/2018-TRU that "We must follow the best international practice in this. We must change IGST law for this if need be. India has a great potential for service export and we must not let it lose competitive edge. Please find away out." An OM dated 14.05.2018 was sent from TRU to GST Policy Wing accordingly. But no reply has been received on the matter. 10. Section 13 (3) (a) was amended vide IGST(Amendment) Act, 2018 to exclude goods for .....

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..... iculture for their livelihood and is the largest producer of spices, pulses, milk, tea, cashew and jute & the 2nd largest producer of wheat, rice, fruits and vegetables, sugarcane, cotton and oilseeds. Currently, India is the world's 4th largest producer of agrochemicals after United States, Japan and China and has emerged as the 13th largest exporter of pesticides globally. 9.2. Pharmaceuticals products are a compound manufactured for use as medicinal drug used to diagnose, cure, treat, or prevent disease. It means any substances resulting from preparing, preserving or compounding of medicinal drugs, vitamins or other materials used to enhance personal health. Pharmaceuticals products are finally sold to end consumer. 9.3. Agrochemicals are chemical products used in agriculture. They comprised of fertilizers, plant-protection chemicals or pesticides, and plant-growth hormones which are designed to protect crops from insects, diseases and weeds by controlling pests that infect, consume or damage the crops. Agrochemicals refers to pesticides including insecticides, herbicides, fungicides and nematicides. Agrochemical products are finally used by farmers. 9.4. Pharmaceuticals and .....

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..... tates that with respect to the toxicology testing is quite similar: acute and chronic testing, reproductive and developmental toxicity, mutagenicity, and others specific testing that will depend on the molecule properties. It is to be inferred that most of the research, development and testing activities depend on the molecule properties of the chemical rather than the chemical getting defined under Pharmaceutical or Agro chemical product. 10.4. Environmental Risk Assessment has to be performed in respect of both set of Agro chemical and Pharmaceutical products. Similarly, metabolites and impurities have to be controlled and tested if they are above a particular threshold. Applicant is of the view that it can be concluded by saying that with respect to Research, Development and Testing process, the activities carried out by both the industries are inter linked with each other and in few cases, the Research, development, testing and analysis are the same. 11.0. The applicant placed reliance on the following Judicial precedents : 11.1. "The Applicant would like to draw reference to certain advance rulings related to the present issue to bring to light the provisions that existed p .....

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..... nly in September 2019 after a long period of wait and upon witnessing multitude of advance ruling applications and representations from taxpayers. 11.6. The /Applicant is of the view, as the intention was to avoid double taxation in respect of research and development services and to tax them at the place of effective use and enjoyment of these services, being the set of services pertaining to pharmaceutical sector were notified, the fact that agro-chemical sector was omitted appears to be merely an oversight. 11.7. The Applicant claimed that considering the similarities between pharmaceutical and agro-chemical sectors discussed earlier and the research and development services provided by the applicant squarely falls under the various types of services provided in the notification, it is most logical that such services with respect to agro-chemical sectors also ought to be treated at par with pharmaceutical sector as the same set of activities are carried out by the applicant in respect of both sectors and therefore, the Applicant is of the view that place of supply in respect of research and development services for agrochemical sector shall be the location of recipient of serv .....

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..... the research and development activities undertaken by the applicant with respect to agrochemical sector and submitted that the description of services as per notification and appellants own business actually looks like identical but there is no description of services under agro chemical sector is mentioned. Further, the Appellant has stated that the notification relating to place of supply of specified services of research and development rendered in respect of pharmaceutical sector was provided only in September 2019 after a long period of wait and upon witnessing multitude of advance ruling applications and representations from taxpayers, from the above point itself it is to be noted that for pharmaceutical sector only notification issued and not covers agrochemical sector, therefore the notification 4/2019 is not applicable to agrochemical sector. 14. The Joint Commissioner (ST), Intelligence-II has also furnished the remark to the effect that no proceeding is pending in their jurisdiction on the subject matter. 15'. The jurisdictional Centre authority vide letter GEXCOM/TECH/GST/ 1436/2023 TECH dated 14.06.2024 has submitted that the question raised by the Applicant is neit .....

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..... lth and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, etc. They further stated that under paras 2.24 to 2.30 of the Exhibit-III (Statement containing the applicant's interpretation of law or facts), they have clearly brought out the nexus between the agrochemical sector and the pharmaceutical sector. Apart from the same, they reiterated that out of the ten "Description of supplies' specified in Table-B of the Notification No.04/2019 Integrated Tax dated 30.09.2019, almost eight of such supply description matches with R&D activities related to Agrochemical sector, though the said notification refers only to the pharmaceutical sector. 16.5. The members took note of the list of sponsors for whom they render R&D services, and requested the AR to provide the nature of testing activities carried out in respect of each sponsor. The AR replied that they would furnish the same in a week's time, along with a brief write-up linking the R & D process. involving Agrochemical and Pharmaceutical sectors. The AR also stated that they have filed an application on 29.12.2023 t .....

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..... lts explaining the methodology used for research, development and testing carried out and same is submitted to the sponsors. During the process of research, development and technical testing, the test items as provided by the sponsors are consumed. Since such items are consumed during the process, they are not returned and they have rendered the above services "in the form of major heads viz, Chemistry, Bio-efficacy and Genetic Toxicology. 17.3. The applicant has been supplying the above services to its sponsors outside India under tax invoice with 18% GST as the applicant's understanding was that the place oi supply for such services falls in India under Section 13 (3) of the IGST Act, 2017 17.4. it is also observed from the statement of facts that the Applicant is recognized as the 'Test Facility' (TF) as per guidelines of NGCMA (i.e.,) National Good Laboratory Practices Compliance Monitoring Authority, which is an Authority constituted based on the Good Laboratory Practices (GLP) as per Organization for Economic Co-Operation and Development (OECD) Principles of GLP. The Applicant has pointed out that Good Laboratory Practice (GLP) is a quality system concerned with the organiz .....

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..... territory, shall be the location of the recipient of service, subject to certain conditions, viz.,- a. Supply of service should be from taxable territory b. Service recipient should be located in a non-taxable territory c. Such supply should fulfill all other conditions of 'export of service except for the condition of the place of supply being outside India. 17.8. Based on the facts of the transaction undertaken by them, the applicant has stated that the conditions prescribed for export of services as per the Section 2 (6) of the IGST Act are satisfied in the present case. The same are enumerated below:- a. the supplier of service, i.e., IIBAT or the Applicant is located in the taxable territory, i.e., India; b. the recipient of service, i.e., the sponsor(s), are located outside India; c. the payment for such service has been received by the supplier of service in convertible foreign exchange; and d. the supplier of service and the recipient of service are not merely establishments of a distinct person in accordance with Explanation 1 in section 8 since they are unrelated entities. 17.9. We find that, in so far as activities listed out in Table B of the notificati .....

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..... d/or the environment. Unless specifically exempted by national legislation, these Principles of Good Laboratory Practice apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals" and they have claimed that considering the same, Agrochemical services shall be treated on par with the Pharmaceutical Services. 17.12. The Applicant also lists out the similarities between the pesticides and drugs to substantiate their stand that starting from the beginning, the early-stage process for discovering new pesticides or new drugs is very similar. Usually, a target or a mechanism of action is identified, and a screening is performed with a library of chemical compounds and the applicant states that the physicochemical parameters used by industry as an initial estimate of the probability of a molecule being a good pharmaceutical or pesticide are very similar. In fact, few of the most common chemical side chains of pharmaceutical molecules are the same as .....

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..... 37 Indian Council of Social Science Research New Delhi Award Letter date 08.07.2019 Geographical Information of Hydrofluorosis in TamilNadu 6 38 Baba Atomic Research Centre, Nuclear Agriculture and Biotechnology Division Mumbai Ref letter dated 05.01.2018 To generate the data on toxicity and environment safety of Ttichoderma koningiopsis 7 41 ICAR Lucknow Service Work Order date 09.03.2020 Services of toxicological analysis of Trichoderma reesei 8 44 ICAR Indian Institute of Horticultural Research Bengaluru Ref date 31.01.2020 Generating toxicological data on "A second set of intraperitonal pathogenicity and eye irritation test" 9 46 CSIR-National Botanical Research Institute, Lucknow Lucknow Purchase Order date 14.03.2022 Container content compatability SAC code 998114 10 49 ISRO Propulsion Complex Mahendiragiri Purchase Order date 13.07.2022 Toxicity evaluation of fuel blend 11 51 Faculty of Agriculture, AAU(Jorhat) Jorhat-13 Ref date 31.03.2022 Toxicity Study of two biopesticides as a part of PG research of the Dept of plant pathology 17.15. On perusal of the abovementioned agreements, it is seen that the entries at s .....

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..... st sample as well as weight in milligram of the same in one square-meter of the test sample. The standard analytical procedures to be followed for the quantification of the said parameters would be furnished by the sponsor. Mosquito net (test sample) on which the analyses to be conducted are physically made available to the Applicant. The most important condition is that service provider shall follow international best practice guidelines to ensure reliability of results and the personnel involved in the activities should be trained in concerned diagnostic chemical science. 18.5. With regard to the second contract made with UNOPS / Cambodia, for Purchase Order date 24/04/202, which is for conducting quality control testing services, in respect of LLIN, otherwise known as Long Lasting' Insecticidal Nets. 18.6. With regard to the third contract entered with Cinemonics / Kenya for Work Order, date 15.03.2024, the Applicant is undertaking quality control testing services of LLIN (Long Lasting Insecticidal Nets) 18.7. in respect of fourth contract Agreement dated 20.03.2023 with Fujian Yamei Industry &Trade Co Ltd, a China based Company, Bio assay - tunnel test services on alpha cype .....

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..... and development services related to pharmaceutical sector as specified in Column (2) and (3) from SI. No. 1 to 10 in the Table B by a person located in taxable territory to a person located in the non-taxable territory." And the relevant entries in Table-B are as reproduced below Table B SI.No. Nature of Supply General Description of Supply (1) (2) (3) 1 Integrated discovery and Development This process involves discovery and development of molecules by pharmaceutical sector for medicinal use. The steps include designing of compound evaluation of the drug metabolism biological activity, manufacture of target' compounds, stability study and long-term toxicology impact.   2 Integrated development 3 Evaluation of the efficacy of new chemical/ biological entities in animal models of disease This is in vivo research (i.e. within the animal) and involves development of customized animal model diseases and administration of novel chemical in doses to animals to evaluate the gene and protein expression in response to disease. In nutshell, this process tries to discover if a novel chemical entity that can reduce or modify the severity of diseases. The novel chemical .....

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..... t of drugs and their metabolites, and biological molecules in unnatural locations or concentrations and macromolecules, proteins, DNA, large molecule drugs and metabolites in biological systems. 18.12. Thus, on careful reading of the list of services enumerated, it is seen that every line entry of the Table 2 of the Notification No.4/2019, involves research and development services in pharmaceutical Sector in connection with study of drugs or disease. But, on perusal of the services rendered by the Applicant from the copies of the agreement filed in paper book, as discussed in para 18.0 to 18.8, we have no doubt that the said services are not circumscribed under the services enumerated as supply of research and development services related to pharmaceutical sector as specified in the Table B of the notification, but found to be relating to the quality studies in respect of long lasting insecticide infused Bed Nets, which are used to give better protection from mosquitoes, bedbugs, cockroaches, houseflies by keeping them away or by killing them. But, the services enumerated under the Notification No. 04/2019 -Integrated Tax, pertaining to research and development in the field of ph .....

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..... the same. 18 14. Further, when the Notification No. 04/2019 - Integrated Tax, with clear and unambiguous language, granted the benefit to the research and development services related to pharmaceutical sector only, benefit shall not be extended to Agrochemical services which admittedly deals with pesticides including insecticides, herbicides, fungicides and nematicides. In this regard, reliance is placed on the orders of the Hon'ble Supreme Court of India in SLP(C) 306/2022, wherein the Hon'ble Supreme Court in the case of Authority for Clarification and Advance Ruling Vs Aakavi Spinning Mills Pvt Ltd, the said judgment was rendered in the context, when exemption on the Hank Yam was denied by citing the Budget Speech, has observed that "The exemption entry being clear and unambiguous, no external aid for interpretation is called for, whether in the form of Budget Speech, or any other notification under any other enactment". 18.15. Furthermore, in Union of India and another vs. Hansoli Devi and others 2002 (7) SCC 273 (vide para 9), the Hon'ble Apex Court observed :- "It is a cardinal principle of construction of a statute that when the language of the statute is plain and unam .....

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..... health and has no nexus with the Notification No. 04/2019-Integrated Tax. The Central Government by Notification No. 04/2019-Integrated Tax, with clear and unambiguous language notified that the place of supply will be the location of recipient of service, only in respect of the supply of research and development services related to pharmaceuticals Sector. Merely for the reason that the Applicant claims m be capable of undertaking/ performing services in relation to pharmaceuticals Sector and that they are recognized by NGCMA, would not be sufficient to cover the services rendered by them in relation to Agrochemical sector, so as to fall within the scope of the said exemption Notification. In this regard, it is important to take note of the fact that the Applicant admittedly have filed GLP Application themselves dated 29.12.2023 before the National Good Laboratory Practice (GLP) Compliance Monitoring Authority for Pharmaceutical Services, to get their test items under the Pharmaceutical sector to be incorporated under GLP Certification. 18.18. In view of the above discussions, we are of the considered opinion that the place of supply in the instant case continues to be covered un .....

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