When was the last time you went to buy medicines and the pharmacist refused to sell them till you gave an original prescription? I’m sure this has happened but certainly not all the time.
But, when was the last time you bought medicines, handed your prescription to the pharmacist, and the pharmacist actually stamped your original prescription and returned it to you? I am confident that the answer to this question would be — NEVER!
This brings us to the very interesting debate going on between offline and online chemists. Like any technology or business that questions and tries to change the status quo, online pharmacies are facing extreme resistance from their offline counterparts on the following grounds:
- Online pharmacies encourage self-medication and illegal purchase of habit-forming drugs;
- Patients can purchase prescription drugs without an original prescription;
- The original prescription can be used for repeated drug purchase.
With this, let us look at the various regulations that govern the sale of drugs and then try and evaluate if online pharmacies are really a boon or bane.
Drugs are divided into various schedules of the Drugs and Cosmetics Act, 1940 (“D&C Act”) and are licensed pursuant to the Drugs and Cosmetics Rules, 1945 (“D&C Rules”). Some are deemed over-the-counter or OTC drugs whereas for others, a prescription is required. These prescription drugs typically fall within Schedule H, H1, and X. When setting up a pharmacy, companies usually apply for licences (pursuant to Rule 61(1) and 61(2)) that permit them to sell, stock, offer for sale or distribute, by wholesale and retail, all drugs except those listed in Schedule X. Of course, there are some that take specific licences to sell Schedule X drugs as well.
Once the specific licences are granted, a pharmacy has to comply with various clauses of the D&C Rules. Some of these compliances are mentioned in Rule 65. Rule 65(2) mandates that “the supply, otherwise than by way of wholesale dealing of any drug supplied on the prescription of a registered medical practitioner shall be effected only by or under the personal supervision of a registered pharmacist.” This rule only applies to retail sales and mandates that any prescription drug be supplied under the personal supervision of a registered pharmacist. Can this requirement be met by online pharmacies? Of course, as long as they sell prescription drugs after reviewing the prescription and the sale is effected by a registered pharmacist. Now, does the law require the prescription only to be in original form? Not at all! In fact, a plain reading of Section 4 of the Information Technology Act, 2000 (“IT Act”), which is a more recent statute, unambiguously clarifies this stand. It states as follows:
“Where any law provides that information or any other matter shall be in writing or in the typewritten or printed form, then, notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied if such information or matter is: (a) rendered or made available in an electronic form; and (b) accessible so as to be usable for a subsequent reference.”
Therefore, if a prescription is in electronic form, it fulfils the requirements of Rule 65(2) of the D&C Rules by virtue of the non-obstante clause in Section 4 of the IT Act.
The second contentious rule is Rule 65(9)(a) that states that “substances specified in Schedule H and Schedule H1 or Schedule X shall not be sold by retail except on and in accordance with the prescription of a registered medical practitioner…..” Rule 65(10) further states that “For the purposes of clause (9) a prescription shall (a) be in writing and be signed by the person giving it with his usual signature and be dated by him; (b) specify the name and address of the person for whose treatment it is given; (c) indicate the total amount of the medicine to be supplied and the dose to be taken.”
Since Rule 65(9)(a) is absolute in nature, the argument put forth by offline chemists is that electronic prescriptions do not conform to Rule 65(10) of the D&C Rules. However, nowhere does Rule 65(10) make reference to the “original” prescription and there is no specific requirement in it that cannot be fulfilled by an electronic copy. Further, as stated above, the IT Act being a more recent legislation shall, to the extent necessary, have an overriding effect on earlier legislations. In fact, this mandate is very clearly highlighted in Section 81 of the IT Act that states:
“The provisions of this Act shall have effect notwithstanding anything inconsistent therewith contained in any other law for the time being in force.”
The last and perhaps the most critical rule is Rule 65(11). It is from this rule that most offline chemists derive maximum thrust to their arguments, irrespective of whether they themselves comply with it or not. Rule 65(11) states that “The person dispensing a prescription containing a drug specified in Schedule H and Schedule H1 and Schedule X shall comply with the following requirements in addition to the other requirements of these rules: (a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once; (b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions; (c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispended.”
The argument put forth by offline pharmacies is that online pharmacies do not comply with Rule 65(11)(c) and because of this non-compliance, they are more likely to also be in breach of Rule 65(11)(a).
At this stage, let us try and recall instances from our personal lives where offline pharmacies have actually complied with Rule 65(11)(c). When was the last time you went to a market with the original prescription and the pharmacist actually stamped it so that you cannot use it again to purchase the same drugs? Almost never! With such rampant non-compliance by offline pharmacies, how would you even know whether the same prescription was used twice or not? If someone wants to misuse the prevailing system, he/she would simply go to another doctor and get the same prescription again. We need a process where the true spirit and intent behind Rule 65(11) would be fulfilled. Now imagine if there was a centralised electronic database that captured details of prescriptions presented at pharmacies and could easily track when the same prescription was re-used to purchase drugs in breach of Rule 65(11)(a)? This is where online pharmacies could become so useful and ensure effective compliance with the intent behind the law.
Notwithstanding this, even if one evaluates Rule 65(11)(c) and 65(11)(a) with a legal lens, neither of the rules make reference to an “original” prescription. Interestingly, the word “prescription” has not been defined in either the D&C Act or the D&C Rules. It has been defined for the very first time by the Pharmacy Council of India in its Pharmacy Practice Regulations, 2015 (“Regulations”). As per section 2(j) of these Regulations, it means a “a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners such as Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated drug to a patient.” Based on this, a simple reading of Rule 65(11)(c) would only go to show how online pharmacies are capable of complying with it. Merely because Rule 65(11)(c) can lead to non-compliance with Rule 65(11)(a) can then not be a ground to prosecute them.
As long as online pharmacies can ascertain and implement creative ways to ensure that prescriptions are stamped (the delivery person can stamp the original prescription, the stamped prescription is returned to the patient with a direction that subsequent purchases would only be permitted if the same stamped prescription is uploaded, etc.), they could, arguably, be in compliance with the D&C Act and D&C Rules. In fact, if the only ground for prosecuting online pharmacies is non-compliance with Rule 65(11)(c), there is absolutely no reason why offline pharmacies should be left outside the ambit of such prosecution. Therefore, the All India Organisation of Chemists and Druggists should be cautious on what arguments they take before regulators and courts in an attempt to go after their online counterparts.
To conclude, I’m sure we know at least one family that boasts of getting their medicines home delivered by giving a phone call to their local pharmacy. Now imagine the same service but with better accountability where the pharmacist dispenses the drug only after making sure there is a valid prescription. That, in short, is how most online pharmacies want to operate. It is a system that balances the need of the consumer and the interest of the regulator. Needless to say, stringent methods should be adopted if companies are found selling without a pharmacy licence or selling drugs that their licence does not permit them to. However, an umbrella ban is never a solution. Imagine what would have happened if Uber was banned because the “interest” of local taxi operators had to be protected? The market would not be competitive and consumers would not get a taste of extremely efficient service. As someone who welcomes technology and business disruptions with open arms, I can already anticipate many benefits- (i) a central database of prescriptions and drugs dispensed that will ensure prescriptions are not re-used contrary to the instructions of the doctors (i.e. better compliance with Rule 65(11)), (ii) data analytics that will help ascertain what type of drugs are prescribed by doctors for specific diseases and result in better R&D by pharmaceutical companies, (iii) immense convenience for patients suffering from chronic diseases where their online orders will ensure timely delivery of medicines, (iv) sale with proper records to avoid any adulterated drugs to penetrate the supply chain and if they do, to be able to track the source, (v) sale of genuine drugs in remote downs and villages where pharmacies are often never audited and do not have enough stock or specialised infrastructure to hold stock for specific drugs, etc.
The need of the hour is specific regulations for online pharmacies that allow them operational efficiency to ensure that the spirit of the D&C Act and D&C Rules is achieved in the long run. After all, when it comes to drugs, the interest of consumers is far more important than that of offline retailers!
(Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the views of YourStory.)
- supply chain
- Pharmaceuticals policy
- Online pharmacies in India
- Drug safety
- Pharmacy Practice Regulations
- drugs and cosmetics act
- offline and online chemists