Applicable Laws & Legal Compliances for E-Pharmacies in India } Best Corporate Lawyer Advice for E-Pharmacy in Delhi NCR | E- Pharmacy Attorney in Delhi NCR | E-Pharmacy Lawyer in Delhi NCR |

E-Pharmacy Lawyer in New Delhi | E-Pharmacy Lawyer in Delhi NCR | E-Pharmacy Lawyer in Delhi | E-Pharmacy Lawyer in Noida | E-Pharmacy Lawyer in Gurugram | E-Pharmacy Attorney in New Delhi | E-Pharmacy Attorney in Delhi NCR | E-Pharmacy Attorney in Delhi | E-Pharmacy Attorney in Noida | E-Pharmacy Attorney in Gurugram | Corporate Lawyer in New Delhi | Corporate Lawyer in Delhi NCR | Corporate Lawyer in Delhi | Corporate Lawyer in Noida | Corporate Lawyer in Gurugram | Corporate Attorney in New Delhi | Corporate Attorney in Delhi NCR | Corporate Attorney in Delhi | Corporate Attorney in Noida | Corporate Attorney in Gurugram |

“The inception of e-pharmacies in India or online medical stores in India is quite novice in nature. Further, the applicable laws upon e-pharmacies in India and the legal compliances for e-pharmacies in India are also at a very rudimentary stage and requires a lot of deliberations. Further, there are a lot of legal challenges for e-pharmacies in India and the Entrepreneur is not well aware of them. The sector has seen a lot of foreign investments as well as domestic cash inflows. Over here we have discussed in detail the legitimacy and legal ambit of e-pharmacies in India.”

Introduction
In the era of online shopping of garments, groceries, equipment, where within a click of a button the need reaches one’s doorstep why medicines are given a back seat? E-pharmacies are virtual platforms wherein the order of medicines is placed on the E-pharmacy website/app using the web and therefore the drugs are delivered to the customer’s chosen address via mail or dedicated delivery companies. This has made life easier as a customer needn’t visit a brick-and-mortar pharmacy to shop for essential medicines. Self-dependent, Internet-only outlets, electronic alternatives of “brick-and-mortar” hospitals, and platforms serving pharmacy companies are included under E-pharmacy companies. These online services in recent times are widely employed by Indian consumers but the laws for these are vague and ill-defined thanks to which it’s subject to varied interpretations.
The three business models employed by E-pharmacies to work are the inventory model whereby the E-pharmacy possesses the stock of medications/drugs and is sold through its own website/app on to the purchasers. Secondly, the marketplace model where the customer is directed to the brick and mortar pharmacy by this E-pharmacy which acts as a platform and an intermediary. Thirdly, the generic model which may be a combination of both under this mode, commercial and sale of pharmaceuticals or any drugs, which could be in violation of the Drugs & Cosmetics Act is prohibited.
The concept of E-pharmacy is received globally by many countries and therefore the Indian market is additionally having an upsurge in demand and use of medicines through E- pharmacy thanks to the massive population. the favored E-pharmacies operating in India are 1 MG, Netmeds, Bookmeds, mChemist, Medlife, Pharmeasy, Medidart, Medstar, Zigy, Save on medicals and Save my meds.

Existing Laws & Legal Framework for E-Pharmacy Business in India: Best Corporate Lawyer Advice
Presently the country doesn’t have any regulatory mechanism for the web sale of medicine and it’s considered that the laws governing the brick-and-mortar pharmacy sector reach E-pharmacies also. The provisions under the Drugs and Cosmetics Act, 1940 (D&C Act), Drugs and Cosmetics Rules, 1945 (D&C Rule), Pharmacy Act, 1948, Information Technology Act, 2000 (IT Act)., Indian Medical Act, 1956 and Code of Ethics Regulations, 2002, Narcotic Drug and Psychotropic Substances (NDPS) Act, 1985 and Medicines and Magic Remedies (Objectionable Advertisement) Act, 1954 are taken as regulatory provisions for manufacture and sale of medicines in India.
Section 18(c) of Drugs and Cosmetics Act, 1940 read along with Rule 65 of Drugs and Cosmetics Rules, 1945 prohibits the manufacturing, distributing, selling, keeping the stock of or exhibiting of any drug unless an appropriate license in accordance with the conditions given under Drugs and Cosmetics Act, 1940 is obtained.

Under Rule 62-B of the Drugs and Cosmetics Rules, 1945 it’s mandated that surely classes of medicine further license is required, to be equipped with adequate storage facilities to preserve the properties of medicine within the premises that’s where the drugs are stored or from where sale/distribution takes place.
Rule 64 of the Drugs and Cosmetics Rules, 1945 says that the pharmacy must cater to certain requirements as prescribed in reference to the equipment furniture and measurements in order that the sale of certain drugs can through a pharmacy. As per Rule 65, of medicine and Cosmetics Rules, 1945 it’s mandatory that the availability or compounding of a particular class of medicine is completed under the private supervision of a registered pharmacist or pursuant to a prescription of a registered medical man wherein such supply has got to be strictly in terms of the prescription which such a prescription is required to be stamped / a noting is required to form on the prescription by the vendor.
Under Rule 65(11-A) of Drugs and Cosmetics Rules,1945 the seller is not allowed to supply any other preparation for certain classes of drugs, even if the said substitute contains the same substances.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is an additional compliance on advertisements by E-pharmacies modulating, those advertisements which suggest the cure for specified diseases and conditions which normally don’t possess any accepted remedies.

The Pharmacy Act, 1948 prescribes for the educational qualifications of pharmacists along with the constitution and composition of a council at the central and state level, to manage the profession of pharmacy in India. Under Section 42 of the above said Act, nobody apart from a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical man.

The Pharmacy Practice Regulations, 2015 framed by the Pharmacy Council of India stipulates the obligations and duties of the pharmacists with reference to the upkeep of records, patient care, secrecy, and counselling along with the preparation and dispensation of medicine. Under Section 9 of the Pharmacy Practice Regulations, 2015 a selected Indian state drug authority is to be constituted.

The “Self- Regulation Code of Conduct for the E-Pharmacy Sector” was launched by the Federation of Indian Chambers of Commerce and Industry on 21 November 2016 which formulated the best professional standards and safeguards ensuring that consumers’ health and safety isn’t compromised. This code prohibited the processing of Schedule X and other habit-forming drugs by E-pharmacy entities but currently, those activities are allowed under the Drugs and Cosmetics Act, 1940 and its Rules upon the filing of essential forms and payment of the prescribed fees. The code also stressed the need to partner with the government for any recall of medicines supported the small print as communicated by the acceptable authorities albeit this Code of Conduct doesn’t have any legal sanctity for fulfilling the necessity of the hour these might be adopted by the government to manage E-pharmacies in India.

Under The Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, certain restrictions such as the prohibition of advertisement of any drugs on radio, television, internet, print, or the other media for any purpose are imposed on the E-pharmacies; and restriction on dealing in narcotic and psychotropic drugs. Additionally, the introduction of monitoring of E-pharmacy and complaint redressal mechanism has provided the rights to file a complaint to the state drugs controller just in case any suspicion of supply of non-standard quality adulterated or misbranded drugs through the E-pharmacy besides the buyer Protection Act, 1986.
In addition to the above mentioned, the Information Technology Act, 2000 and rules lay down provisions to run a web-portal, while the E-Commerce Rules has provided detailed obligations of an e-commerce entity or marketplace e-commerce entity which qualify as ‘intermediaries’ under Section 2(1)(w) of the knowledge Technology Act, 2000 as they facilitate the web sale and delivery of medicine from the physical registered pharmacies they need a tie-up with.

Legal Challenges faced by E-Pharmacies in India: Best Corporate Legal Solutions for E-Pharmacies in India
Even though there are legislations governing E-pharmacies operations in India, there are certain concerns and challenges to an equivalent that is:
No specific provisions in reference to the web sale of medicines are given under the Drugs and Cosmetics Act, 1945, and its rules. The Office of Drug Controller in 2015 had cleared this doubt by clarifying that the Drugs and Cosmetics Act, 1940 and Rules of 1945 don’t see the brick and mortar pharmacy and online sale of medicine as any different. The Self-Regulation Code of Conduct released by FICCI in 2016, cannot be claimed to have the force of law for the regulation of E-pharmacies.
Another point of concern is that these existing regulations which govern the E-pharmacies that are the Drugs and Cosmetics Act, 1940, and therefore the related rules of 1945 are archaic legislation that was enacted before the approaching of the web, hence only considered the sale of medicines through physical stores. The risks and issues concerning the web sale of medicines weren’t considered.

Under the Pharmacy Act, 1948 and the Drugs and Cosmetics Rules, 1945 registered pharmacists could only dispense medicines upon availing the prescription of a medical man but within the case of E-pharmacies, no confirmation are often as long as the dispensation of medicine is completed through a registered pharmacist. Furthermore, counselling of a patient regarding the usage of the drugs, the side effects, etc., while purchasing drugs might not be practically possible on an E-pharmacy platform as given under the Pharmacy Practise Regulations 2015. The answer to this is to limit the web sale of medicine to only over-the-counter medicines that’s not necessary to be dispensed by a pharmacist.

In the current regulatory framework, there’s no mechanism for verification and authentication of the scanned prescriptions so as to urge prescription medicines through an E-pharmacy. A customer has got to upload a scanned copy of the prescription on the web site. This may become an electronic record within the meaning of the Information Technology Act, 2000 which needs an electronic/digital signature for its authentication. These scanned copies of prescriptions are often easily manipulated or doctored resulting in overuse of medicine hence becoming a threat to future generations. Under the E-pharmacy mechanism, no noting is ensured as per Rule 65 of the Drugs and Cosmetics Rules, 1945 which could have stopped the use of the same prescription repeatedly on different E-pharmacies.

As per Section 18(c) Drugs and Cosmetics Act, 1940 for a pharmacy to operate, it has to be registered and E-pharmacies also have to be registered. The possibility of commencing an E-pharmacy which is unregistered or one that does not have a license could affect the health of the consumers if they end up selling low-quality or contrived drugs. There is a need for a designated authority that can identify and block illegal websites selling such medicines.
The confidentiality of the information given in the prescriptions that are uploaded on these E-pharmacy portals has to be ensured since if such sensitive healthcare data is leaked it will be taken as a violation of the Right to Privacy under Article 21 of the Constitution. Thus it is the duty of these E-pharmacies to keep up with the privacy policies.

Medicines must be handled with due care and caution. It must be kept in specific temperatures and conditions so that it doesn’t lose its potency. Under the present legal framework, vague provisions relating to the transportation and storage of drugs are given.
Due to the coming of these E-pharmacies, brick-and-mortar pharmacies and medical practitioners have got a major hit. They contend that the fall foul of Indian regulations would create risks of forged prescriptions and exploitation of prescription drugs for the end customer. This issue was acknowledged by two Hon’ble High Courts taking divergent positions on the online sale of drugs. The Delhi High Court in the case of Dr. Zaheer Ahmed V. Union of India [Writ Petition(c) No.11711/2018] prohibited the same, and the Madras High Court in the case of Practo Technologies V. Tamil Nadu Chemists and Druggists Association [W.P. No. 28716 of 2018] allowing the same till the government brought into effect its rules on E-pharmacies. In the case of Dr. Zaheer Ahmed V. Union of India, the Delhi High Court had ordered an injunction for the online sale of medicines without a license in which a petition challenging the unregulated online sale of drugs and abuse of medicines was filed before the Delhi High Court. The Delhi High Court relying on the interim ban imposed by the Madras High Court in October 2018 passed an order to stay the online sale of medicines without a license. In the case of Practo Technologies V. Tamil Nadu Chemists and Druggists Association, the Madras High Court had banned the online sale of medicines till the government notified the 2018 draft rules. The High Court of Madras acknowledged the various advantages of the technology of e-commerce while also taking into account the issues like self-medication and control of illegal sale by unlicensed entities under the existing legislation. Then after in December 2018 the High Court of Madras directed the Central Government to notify the final version of the draft rules by 31 January 2019 which was not fulfilled and finally in January 2019 on appeal, the High Court of Madras stayed its earlier order of banning online sale of drugs by pointing out that online sale has been occurring for quite some time and a sudden ban would cause inconvenience to the patients.
In order to resolve these issues, there is an urgent need for new comprehensive legislation to cover these gaps in the regulatory mechanism and cater to the requirements of the E-pharmacy entities. The formalization of draft rules governing e-pharmacies, first notified in 2018 which is now intended to be an amendment to the Drugs and Cosmetics Rules, 1945 vide insertion of a proposed Part VIB will give legal sanctity to this grey field of law.

Draft of the E-pharmacy Draft Rules under Drugs and Cosmetics Rules 1945
In July 2015 the Union Health Ministry and other regulators had joined together to create an expert committee known as the 48th Drug Consultative Committee to evaluate the potential and viability of the Indian online pharmacy sector. The chairman of this committee was the then Maharashtra FDA Commissioner Dr. Harshdeep Kamble. After multiple discussions and consultations the Union Health Ministry by way of its notification G.S.R. 817 (E) on 28 August 2018 came up with the detailed collection of the draft regulations to amend the Drugs and Cosmetics Rules, 1945 by including specific provisions for regulating online pharmacies in the country. From that time this concept of E-pharmacy got some attention but still, the draft rule has not been notified and is waiting for enforcement.
Part VIB of the Draft Rules stipulates the terms of sale by E-pharmacies. According to the draft rules, ‘E-pharmacy’ is defined as the transactions of distribution or sale, stock, exhibit, or offer for vending drugs through web portals or other electronic modes. The Draft Rules provide three relevant definitions, which are “E-pharmacy”, “E-pharmacy portal” and ‘sale by way of E-pharmacy” along with the mandate for the registration of E-pharmacies.
The Draft Rules contain the following provisions:

1. Registration: Any individual who is intending to start the E-pharmacies has to compulsorily enrol for registration to the Central Licensing Authority by filling up Form 18AA and paying INR 50,000 as registration fee along with providing essential files to the Central Government through its net portal before the onset of the proceedings. Registration is obligatory for the functions of selling, distributing, stocking, exhibiting, or providing on the market of medication via the E-pharmacy portal through any individual and the validity of the same is 3 years. There is a provision of license renewal if the Pharmacy is keen on continuing its operations. This registration can be suspended or cancelled, in case the E-pharmacy registration holder contravenes any provision of the Drugs and Cosmetics Act, 1940, and the allied rules of 1945. [Rule 67(Q), Drugs and Cosmetics (Amendment) Rules, 2018, Rule 67(R) Drugs and Cosmetics (Amendment) Rules, 2018]
2. Procedure for Distribution or Sale of Drugs: At the time of receipt of a prescription, the registered pharmacist is required to verify the details of the patient, registered medical practitioner and make arrangements to dispense the drugs on behalf of the E- pharmacy from any licensed premises under the Drugs and Cosmetics Act, 1940. Along with this the details of the drugs dispensed and the patient have to be maintained.[Rule 67(P), Drugs and Cosmetics (Amendment) Rules, 2018]
3. Data Privacy: The rules also instruct the maintenance of non-disclosure and confidentiality regarding any information procured from customers through a prescription or otherwise, except to the Central and State government, if needed, for measures of public health. The storage of health information gathered or cloned by the platforms ought to be done within domestic borders, which means, it shall not be kept or dispatched outside the Indian Territory. [Rule 67(M)(2), 67(K), Drugs and Cosmetics (Amendment) Rules, 2018]
4. Code of Conduct: Rule 67-M of the draft stipulates terms like compliance with the Information Technology Act, 2000 and correlating rules, such as briefing the Central License Authority of any alteration in the code of conduct of the said E-pharmacy.
5. Grievance Redressal System: They also mandate a Compulsory 24×7 customer support facility and the presence of a grievance redressal system. [Rule 67(J)(4), Drugs and Cosmetics (Amendment) Rules, 2018]
6. Restriction of Illegal Trade: The trade of drugs encapsulated under the Narcotic Drugs and Psychotropic Substances act, 1985, along with tranquilizers and drugs mentioned under Schedule X of Drugs and Cosmetics Rules, 1945, is prescribed under the Draft rules. [Rule 67(M)(5), Drugs and Cosmetics (Amendment) Rules, 2018]
7. Maintenance of Cash Records: In order to keep a check on counterfeit drugs, unauthorized sale, and expired drugs the cash or credit memoranda must be maintained which should mandatorily have substantiation of the details of the patient, the medical practitioner, details of the drugs and the e pharmacy must be given on the prescription. [Rule 67(M)(3), Drugs and Cosmetics (Amendment) Rules, 2018]
8. Monitoring: The Central License Authority has to regularly monitor in order to ascertain compliance with the terms of registration which has been specified. The Authority possesses the right of suspension to cancellation of the e-pharmacy registration upon the issuance of a show-cause notice at the time of non-adherence to the rules.
9. Inspection: The Central or State Licensing Authority must inspect the premises of the E-pharmacy business every 2 years, in addition to it, the Licensing Authority is to ensure that all information regarding the availability of the drugs, types of drugs listed for sale, supply channels or vendor committed, details of registered pharmacists, registered medical practitioner, are being accurately maintained by the registration holder. [Rule 67(O), Drugs and Cosmetics (Amendment) Rules, 2018, Rule 67(V), Drugs and Cosmetics (Amendment) Rules, 2018]

 

Critically analyzing the draft provisions it can note that there are lacunae in the draft rules. Firstly, in the draft rules, only those E-pharmacies are allowed to operate which are registered under the Central Licensing Authority so it must be noted that at this juncture when governments worldwide are having a tough time with the issue of eliminating illegal E-pharmacies as these sell low-quality medicine in unregulated quantities or are substandard medicines it becomes further problematic to identify those spurious websites and hold them responsible for their actions.
Secondly, the draft rules have stipulated for periodic inspection of the registered pharmacies and cancellation at the time of non-adherence but no mechanism is provided to deal with illegitimate websites or to penalize them. The draft must also have included fine or penal provisions for the purpose of imposing liability on such websites and create consumer awareness among the consumers.
Thirdly, although the E-prescriptions are given a mention in the draft rules the issues is not comprehensively dealt with as its focuses on the responsibility of the online pharmacies to verify the prescriptions but the consumers must also be obligated not to provide fake prescriptions or use the same prescriptions in one or more websites. In case of such situations, the E-pharmacies must provide information to the concerned authorities. In order to curb such issues, a nationwide database linked to e-prescriptions of the patient must be there which will alert the concerned persons but for these combined efforts of online pharmacies, doctors, patients, and the government is required.
Fourthly, online pharmacies must not disclose any information of the customer to any third party but for health purposes to the government. This cannot be entirely accepted since “the health purposes” has a broad ambit and allowing government without even specifying the minimum designation of the authority that uses the data is a blatant violation of the Right to Privacy enshrined under Article 21 of the Constitution. As a solution to this, the E-pharmacies must inform the consumers of the privacy policy by displaying it on the websites and this must be included in the draft rules too.
Fifthly, these draft rules are not inclusive of the online sale of lifestyle drugs. Lifestyle or habit-forming activities like smoking, alcoholism, or overeating though not necessarily become an addiction can be detrimental to individuals with other health issues so regulation in that regard is also required under these draft rules.

A time period is not specified for which E-pharmacies are required to keep details of the drugs dispensed and the patient’s details in their web portal. Lastly, under the Draft Rules, the data of a patient cannot be sent outside India but this notion is not in parlance with the Personal Data Protection Bill, 2019 which allows the transfer of sensitive data with the consent of the patient.
This legislation is a step in the right direction and when combined with the Information Technology Act 2000 and the Personal Data Protection Bill, 2019 can be highly effective in ensuring the confidentiality of the medical information of citizens.

Foreign Direct Investments (FDI) IN India & the E-Pharmacies: Best FDI Attorney Legal Advice in India
There has been a significant upsurge in the online pharmacies in the country and is also opening a new area for investors across the globe. Indian E-pharmacy business has got the capacity to capture 5-15% share with a value of approximately 1000 billion INR. The Indian Brand Equity Foundation’s report on the Indian pharmaceutical industry displayed that Indian’s contribution to generic global exports is about 20%. As per the report by Frost & Sullivan, there is an expectation that the E-pharmacy market will reach INR 25000 by 2022. There are speculations of growth in this field which is now at a seedling stage. Innovative concepts, adaptation to the dynamic business environment, catering to the rapidly changing consumer demands, ease of doing business opportunities, favourable regulatory mechanisms, and economic growth in India will usher this industry at an unprecedented level making India a global market in the field of E-pharmacy.
It is imperative to understand whether the investment is likely possible in the trading sector rather than the pharmaceutical sector. A hundred per cent FDI is allowed in both sectors but there are certain conditions or restrictions in both. If the trading sector is considered, then it will likely fall under e-commerce which itself has an inventory-based model and marketplace model. For compliance with FDI in market place model, detailed conditions need to be fulfilled and FDI in the inventory-based model is restricted. In order to make investment viable formulation of business and legal structure is required.
Draft rules will bring in greater clarity with regard to rules inoperative structure but since the existing regulatory framework doesn’t have a blanket prohibition to E-pharmacies there arise a need for better legislation in matters of license/registration. FDI must take place in a compliant marketplace model of E-pharmacy in addition to its compliance with regard to e-commerce regulations under consumer protection law and data protection regulations should also be looked at.
Even though there is considerable growth in this field, given the delicate character of the pharmacy industry and the multiple layers of the compliance obligations that chains the various aspects of pharmaceutical products especially sale and storage matters, this rise of E-pharmacy activities in India has, unfortunately, looks upon with suspicion by the local regulatory authorities engulfing it in a pool of controversies.
However, increased risk of self-medication by the patients including drug misuse and addiction, sale of counterfeit/substandard medicines without any accountability, and poor storage conditions are certain public health concerns that makes it reasonable for these controversies and the ensuing regulatory interference disregard of the applicable laws and regulations.

Pros and Cons of E-Pharmacies: Best Corporate Legal Solutions
The online pharmacy business has got a lot of advantages but it has got its share of controversies too. It is much more cost-effective as the prices are lowered than the market price because of attractive sales and offers. This is a more convenient method for buying medicine since at the comfort of one’s home; medicines can be bought which reach our doorstep with just a click of a button. It helps patients with long-time medication. It has got lower transaction and product costs. It offers greater accessibility to people with limited mobility and remote areas. All types of information with regard to the contents of the medicine, expiry, side effects, substitutes, frequency of taking the medicines, discounts, suppliers information, return options, etc. are specified in the order confirmation. Since Online pharmacies reduce transactional costs and the costs of obtaining pharmaceuticals through a more efficient centralized order-processing system. It provides services such as media alerts at the time when the medicine is about to get over so that the consumer is not short of essential lifesaving medicines or drugs.
Apart from the advantage to the consumers, the regulators have got certain advantages such as better tracking of data, the legitimacy of the medicine, documentation and tax compliance, and growth in business due to the innovation. These online pharmacies widen the horizon of the pharmaceutical business making life-saving medicines available at the doorstep within a short span of time.
Online pharmacies are viewed with suspicion since it is a matter of the health of people and one wrong medicine can be a threat to human life which is irreparable damage. The cons of this business can be a fatality and severe reactions due to wrong medicine, consumption of diet pills, illegal use of medicines, excessive quantity dispensed through e pharmacies, counterfeit medicines, etc. apart from these illegal websites selling low-quality medicines, dud medicines, sugar pills, expired, or contaminated drugs can pose risk to patients. Lack of proper monitoring encourages fraudulent practices like sending wrong dosages or substitutes of what is prescribed. There is no face-to-face contact with the medical practitioner. The efficiency of the registered medical practitioner mentioned on the website may not be accurate. Privacy of the healthcare data of the patient is put under question if the website doesn’t have privacy policies or cookies.

Recent Developments in E-Pharmacy
Since the announcement of the lockdown, the Ministry of Health and Family welfare had also by way of a notification dated 28th March 2020 allowed the sale of medicine including the drugs laid out in Schedule H, Schedule H1, and Schedule X (except narcotics, psychotropic, and controlled substances as defined in Narcotics Drugs and Psychotropic Substances Act 1985) to be delivered at the doorstep by any license holder under Form 20 (drugs aside from those in Schedule C, C(1) & X), or Form 21 (drugs aside from those in Schedule X) of Drugs and Cosmetics Act,1945.

The Notification places the subsequent conditions for delivery of Schedule H:
a. The sale to be effected supported by the receipt of prescription physically or through an email;
b. The license holder to submit the e-mail id for registration with licensing authority of prescriptions is to be received through email;
c. The drugs to be supplied at the doorstep where the patient is found within an equivalent revenue district where the licensee is located;
d. In case of chronic diseases, the drugs is to be dispensed as long as it’s presented to the license holder within 30 days of the date of prescription, and in acute cases, the drugs is to be dispensed as long as it’s presented to the license holder with 7 days of its issue;
e. The bill or cash memo shall be sent by return email and records of all such transactions shall be maintained by the license holder.

The Federation of Indian Chambers of Commerce and Industry in January 2020 had forced the ministry for the dissemination of Draft Rules as a matter of high priority for mitigating the shortage of certainty among different stakeholders. It also exhorted that E-pharmacy stores are in according to the aims of national advancement. Meanwhile, a high-level group of ministers no matter having been approved by the Drugs Consultative Committee and Drugs Technical Advisory Board is considering the Draft rules which is for the aim of fine-tuning the proposals apropos reservations by traditional medical pharmacists.
The intellectual property rights protection of the E-pharmacies or digital health is analyzed with reference to the Section 3(k) of Indian patents Act, 1970 under which computer program is excluded from patentability. The computer-related invention in itself isn’t patentable but under the ‘Guidelines for Examination of Computer Related Inventions (“CRI”)’ issued by the Indian Patent Office in 2017, CRI claimed in conjunction with novel hardware are often patented, provided it satisfies the wants as stipulated within the guidelines.

Under the Copyright Right Act, 1957 copyright protection of clinical guidelines and data in Digital Health could also be granted by the originality of the content but might not exist as long as the creator of such database has undertaken such an activity independently. The ‘mark’ of a Digital Health application could also be registered as a trademark under the Trademark Act, 1999 subject to exclusion under Section 9 and 11 of the Trademark Act which may form the grounds for refusal of the trademark. Intrinsically, trade secrets aren’t protected under any legislation within the country, while the mixture of a Non-disclosure Agreement with a Non-Compete Clause shall add a further stratum for cover of proprietary knowledge and tip of the business, in absence of exclusive legislation on trade secrets in India.

Conclusion
This covid scenario within the country has created an area for the E-pharmacy to penetrate into the lives of the people especially for the explanations that one doesn’t need to visit physical stores. E-pharmacies are the necessity of the hour and regulating them has become imperative taking into consideration the health of the people. For effective regulations of those E-pharmacies, the policymakers can take influence from the regulatory framework of nations just like the USA and therefore the EU. The gaps persisting within the regulatory framework are often filled by the enforcement of the Draft Rules under the Drugs and Cosmetics Rules, 1945. The government possesses the duty to make sure the health of its citizens and even it’s the Fundamental right enshrined under Article 21 of the Constitution so urgent steps got to be taken for giving legal sanctity to E-pharmacies.
Authored By: Adv. Anant Sharma & Jyotsna Jose