The West Bengal drug control administration issued a circular in October 2018 directing all the chemists and druggists in the state to dispense medicines as per the requirement of the consumers, whether it is one tablet or one capsule rather than giving the entire strip of the drug. Giving a stern warning to the more than 30,000 chemists in the state, the director of the West Bengal drug control administration stated in the circular that the offenders will be punished as per Section 65 of the Drugs and Cosmetics Rules.

The directive has stirred a hornet’s nest as arguments have long been flying thick and fast for and against the practice of cutting of strips by pharmacists. In fact, there is a lot of confusion on the issue amongst the pharmacist community as well as amongst regulatory officials as there is no clear-cut provisions in the law whether strip cutting is allowed or not; and regulatory officials have different views on the matter.  While some regulatory authorities say that strips must be cut if a patient desires, or doctor prescribes so, pharmacists argue that the Rule 65 being quoted by the drug authorities to make strip cutting compulsory is irrelevant today as it was formulated much before strips actually came into existence in the country.

Rule 65 of the Drugs and Cosmetics Rules prescribes condition of licences. in [Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B]

The above licenses are subject to the following conditions:

Any drug shall, if compounded or made on the licensee ‘s premises be compounded or made by or under the direct and personal supervision of a registered Pharmacist

 The supply otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be affected only by or under the personal supervision of a registered Pharmacist.

Sub-rule 19 of Rule 65 states that the supply by retail of any drug in a container other than the one in which the manufacturer has marketed the drug, shall be made only by dealers who employ the services of a Registered Pharmacist, and such supply shall be made under the direct supervision of the Registered Pharmacist in an envelope or other suitable wrapper or container showing the following particulars on the label:

(a) name of the drug,

(b) the quantity supplied,

(c) the name and address of the dealer.

Further as per Pharmacy Regulation

  • Compounding means the preparation, mixing, assembling, packing, or labelling of a drug or device as the result of a practitioner’s prescription drug order (or) initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice,
  • Compounding also includes the preparation of drugs or devices in anticipation of prescription and observed prescribing patterns.
  • Dispensing means the interpretation, evaluation, supply, and implementation of a prescription, or drug order, including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container appropriately labelled for subsequent administration to, or use by, a patient.

As per section 9.1 of the Act The various activities of dispensing (prescription assembly) like removal of drugs from the packing, filling the prescription etc. may be performed under the supervision of a registered pharmacist by any person who has been trained to perform these activities. However, the actual dispensing of drugs to patients shall only be performed by the Registered pharmacist after due verification of the prescription filled by others.

Compounding, dispensing, and labelling of required drug products should ensure that:

 the drug product matches the prescription.

 (ii) The drug product has not expired.

(iii) The drug product is appropriately compounded (if necessary), packed, and labelled appropriately.

(iv) The accuracy of dispensing is checked by Registered Pharmacist. (v) Proper documentation is made.

(h) Delivery of the drug product to the patient/carer is done in such a way as to ensure that the Registered pharmacist hands over the drug to the patient/carer and appropriate information on drugs is provided to the patient/ carer.

According to news reports, the Department of consumer affairs has held its first meeting on this issue of forcing customers to buy entire tablet strips at pharmacies, with senior representatives in the pharma and medical devices industry. The Drug Controller General of India (DCGI) senior officials were also present at the meeting.

One of the few solutions suggested at the meeting involved the use of new technologies in the packaging of these medicines to help protect consumer interest, added the news reports.

For example, the plan that has been proposed by the consumer affairs ministry is to sell “perforated medicine strips” with each segment of the strip carrying the manufacturing and expiry dates. This will help the consumer to get complete information of the medicine even if they need to buy only a few tablets instead of the entire strip. Also, it will be easy for the chemist to cut it wherever possible. Use of QR code is also suggested.

In view of the above provisions under Rule 65 (19) of Drugs and Cosmetics Rules 1945 read with Pharmacy Practice Rules 2015 provides sufficient support to sale of cut strip by a registered pharmacist under a valid prescription.