ADVISORY ON DIGITAL PRESCRIPTION

  1. PRESCRIPTIONS WHERE THE DOCTORS HAVE MENTIONED “SUBSTITUTES ALLOWED” IN THE PRESCRIPTION.

 Generic drug/medicine:

 A generic drug is defined as a drug product that is comparable to the brand/reference listed product in dosage in dosage form, strength, route of administration, quality, and performance characteristics, and intended use.  Only a Registered Medical Practitioner (R.M.P.) who is registered with the respective State Medical Council is authorized to prescribe allopathic medicines.

A prescription is a legal document governed by the following laws:

  • National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations,2022
  • The Indian Medical Council (Professional Conduct, Etiquette & Ethics) Regulations, 2002
  • The Drugs and Cosmetics Act, 1940 and Rules 1945
  • The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and
  • Rules 1955
  1. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:

 There is a guideline for the RMPs to prescribe drugs with generic/pharmacological names only. However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed.

Also, Regulation 1.5 of the Regulations stipulates that as far as possible, drugs should be prescribed with generic names. Every doctor should make sure that there is a rational prescription and use of drugs.

These guidelines state that physicians should recognize and promote the practice of pharmacy as a profession and should seek their cooperation wherever required. Hence, the use of generic names is encouraged by the authorities so that a pharmacist can choose a low-cost substitute for the same medicine.

  1. National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022:

 These Regulations state that every RMP is expected to prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.

There is a sample template provided for the reference of the RMPS:

SAMPLE PRESCRIPTION

 

 

Registration no:  XXX

Name:

Address

Emergency Contact number:

Patient name:

Date:

Age:

Sex:

Weight:

Height

 

Diagnosis/Provisional Diagnosis:

Rx

 

1. Inj…mg IV/IM…. hourly for……days

2. Tab/Cap….mg per oral after food three times a day for 3 days

3. Syrup/suspension…ml per oral after food three times a day for 3 days

4. Oint/gel/cream… Necessary quantity/fingertip to be applied over the affected area…. times a day till improvement.

5.EyeDropsXXXX—drops to be instilled in the right/left eye every 6thhourly for 3 days

 

Not to be repeated

 

To review after 3 days

 

Signature

 

(With Seal)

 

Name

 

Unique ID/Reg No (NMC)

 

(Qualification)

        iii.          Telemedicine practice guidelines in India:

Consultation through Telemedicine by the RMPs shall be permissible following the Guidelines, if the RMP has prescribed medicines, RMP shall issue a prescription as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations and shall not contravene the provisions of the Drugs and Cosmetics Act and Rules.

RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform.

Suggested sample format in Telemedicine Guidelines:

  1. The Drugs and Cosmetics Act, 1940 and Rules 1945:

 

The D&C Act, under Section 65, stipulates that there are certain Conditions to the Licenses under this Act.

Any drug shall be compounded in the licensed premises under the supervision of a Registered Pharmacist. Hence, the dispensing of the substituted medicine must be under the supervision of a Registered Pharmacist. There is a prohibition on dispensing any other preparation, whether containing the same substance or not for the drugs specified in Schedule H, Schedule H1 and Schedule X (Section 65 (11-A), D&C Act 1940). It is also suggested to add a disclaimer stating that all the information regarding substitutes of the drugs is provided by a Registered Pharmacist in licensed premises.

  1. A THIRD PAGE WHERE WE CAN PROMOTE PRODUCTS RELEVANT TO THE USER FROM DIFFERENT BRAND

 Marketing advertisements relating to Drugs is prohibited under various regulations and guidelines (Drugs & Cosmetics Act, 1940, Rules, 1945, and Drugs and Magical Remedies (objectionable) Act 1954) unless permitted by the central government, licencing authorities, or exempted from the application of the Acts.

  1. Drugs & Cosmetics Act,1940, Drugs & Cosmetics Rules 1945:

Rule 74 and 78 of the Drugs & Cosmetic Rules and states that no advertisement can be made in respect of Schedule H, H1 and X except with the previous sanction of the Central Government.

  1. Advertisement of Ayurveda Drugs:

 The Central Government amended the Drugs & Cosmetics Rule, 1945 and Rule 170 is inserted in Part XIX to prohibit the advertisement of Ayurveda, Siddha, and Unani drugs unless a unique identification number is obtained from the licensing authority.

  • Drugs and Magic Remedies (Objectionable Advertisements) Act 1954:

 The promotion of medicinal products in India is primarily regulated by the DMR Act and its associated Rules. The DMR Act stipulates that any advertisement of a drug that suggests or leads to the use of a drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in its schedule is prohibited in India. At the time of writing, the schedule under the DMR Act contains 54 diseases. A recently proposed amendment to the DMR Act proposes to expand the list to 78 diseases.

  1. Uniform Code for Medical Device Marketing Practices

 UCPMP Code prohibits any inducements to healthcare professionals to prescribe, sell, supply, or recommend the use of a particular medicinal product and, under the MOHFW Notification, these restrictions apply to medical devices as well.

Promotional material has been defined as materials used by a medical devices company for the commercial promotion of its products and services either to a Healthcare Professional or to a patient directly. This applies to all marketing materials and advertisements of the company. Also, Compliance under the UCPMP Code is enforced by the ethics committee for pharmaceutical marketing practices (ECPMP).