NDPS rules for doctors: prescribing and stocking Essential narcotic drugs after the 2015 amendment: prescriptions, registers, and recognised medical institutions.

The NDPS Act, 1985 allows narcotic drugs only "for medical or scientific purposes and in the manner and to the extent provided" by the Act and the rules (section 8). For the drugs a clinic is most likely to meet, the governing rules are Chapters VA and VB of the NDPS Rules, 1985, inserted by G.S.R. 359(E) on 5 May 2015. They let a registered medical practitioner (RMP) possess a limited quantity for use in practice, set the prescription format, require two registers, and create a recognition route for clinics and hospitals that stock and dispense. This post covers what the rules require of the doctor and the clinic. Which drug, for whom and at what dose is a clinical decision this post does not touch.

What is an essential narcotic drug?

Section 2(viiia) of the Act, added in 2014 with effect from 1 May 2014, defines it as "a narcotic drug notified by the Central Government for medical and scientific use". Section 9(1)(a)(va) then gave the Central Government power to regulate their "manufacture, possession, transport, import inter-State, export inter-State, sale, purchase, consumption and use" by rules, which is what Chapter VA does. The table in rule 52A(3), which sets what an individual doctor may hold, lists morphine and its salts and preparations, codeine and ethyl morphine, oxycodone, hydrocodone and fentanyl, each with qualifications in the rule's own words. Read the table itself before relying on any list.

The rules attach their own meaning to "registered medical practitioner" for this chapter: a doctor or dentist on the register who "has undergone training in pain relief and palliative care for prescription of essential narcotic drugs for pain relief and palliative care or training in opioid substitution therapy for prescription of essential narcotic drugs for treatment of opioid dependence". If you prescribe these drugs, keep the certificate of that training in your file.

What must the prescription contain?

Rule 52G sets two conditions. The prescription "shall be in writing, dated and signed by the practitioner with his full name, address and registration number" and "shall specify the name and address of the person to whom the prescription is given and the total quantity of the essential narcotic drug to be supplied alongwith daily dose and period of consumption". For a patent or proprietary medicine, "it shall be sufficient to state the quantity and strength of the medicine to be supplied". And it "shall not be given for the use of the prescriber himself". On the chemist's side, rule 52F(2) says a licensed chemist "shall sell essential narcotic drug only on prescription".

• Your full name, address and registration number on the pad, not just a stamp of the clinic name.
• The patient's name and address.
• The total quantity to be supplied, the daily dose and the period.
• The date and your signature.

Prescribing by teleconsultation has its own limits; see our telemedicine guidelines summary. For the general contents of any prescription, see what a prescription must contain.

Can a doctor keep a stock at the clinic?

Yes, within limits. Rule 52A(3): an RMP "may possess essential narcotic drug, for use in his practice but not for sale or distribution", up to the quantity in the rule's table for each drug. The Explanation narrows "for use in his practice" to "the actual direct administration of the drugs to a patient under the care of the registered medical practitioner". So a doctor's own stock is for administering at the clinic or on a visit, not for handing out strips. Rule 52F(1) lets a manufacturer or licensed dealer sell to an RMP without a prescription.

A doctor who needs more can ask the Controller of Drugs, who may authorise a larger quantity by special order, granted or renewed "for a period not exceeding three years at a time"; renewal is applied for at least thirty days before expiry (rule 52A(4)). The Controller can also prohibit a doctor from holding these drugs if the doctor has violated the rules, been convicted under the Act, or in the Controller's opinion "abused such possession", and the stock must then be handed over (rule 52A(5)). The Controller of Drugs is the officer each state appoints as controlling authority under rule 50 of the Drugs and Cosmetics Rules, 1945.

What records must the doctor keep?

Expired stock is destroyed "in such manner as may be specified by the Controller of Drugs" (rule 52M(2)); at an RMI it is destroyed in the presence of an officer the Controller nominates (rule 52V(1)). Supply invoices or consignment notes are kept for two years under rule 52D. Keep the forms themselves, in the format the rules prescribe, rather than a home-made register.

When does a clinic need RMI recognition, and how?

A clinic that wants to hold stock beyond the individual doctor's limits, and dispense or sell to registered patients, needs to be a recognised medical institution. The rules define a medical institution widely, including a "hospital, dispensary, clinic or an institution by whatever name called" run by government or "any person or body of persons". Government, municipal and zilla parishad hospitals with at least one trained RMP are deemed recognised and exempt only from applying (rule 52N). A private clinic applies.

1. Apply in Form 3F to the Controller of Drugs (rule 52-O(1)).
2. The Controller issues a Certificate of Recognition in Form 3G "within sixty days" of receiving the application, or tells you the reasons for delay (rule 52-O(2) and (3)).
3. Designate one or more trained RMPs who will prescribe and dispense, and one as over-all in charge; their names are endorsed on the certificate. Report a change within seven days (rule 52Q).
4. The designated doctor registers each patient who will receive these drugs and keeps Forms 3E and 3H (rule 52R).
5. Hold stock only up to your filed annual estimate (rule 52U), and file the Form 3J estimate and the Form 3-I return on time (rules 52T and 52R).
6. Renew at least sixty days before expiry; recognition runs "for a period not exceeding three years at a time" (rule 52-O(4) and (5)).

Other conditions: drugs returned unused by patients are entered as receipts; stock may not be transferred, loaned or sold to another institution without the Controller's prior approval (rule 52V); trained staff may carry the drugs for home care of a registered patient, but "home care treatment shall not be provided for treatment of opioid dependence" (rule 52W); stocks are open to inspection by the Controller (rule 52Y). The Controller may suspend or cancel recognition after a show-cause opportunity (rule 52P), and an appeal lies to the state secretary responsible for the Drugs and Cosmetics Rules within sixty days (rule 52Z).

What happens if the rules are not followed?

Section 8 of the Act allows narcotic drugs only in the manner the rules provide, so possession outside the rules is outside the medical exemption. For a breach of a rule or a condition of an authorisation that carries no separate punishment, section 32 provides imprisonment up to six months, a fine, or both. Other sections of Chapter IV, "Offences and Penalties", deal with other contraventions, including section 21 for manufactured drugs and preparations; if an inspector raises a question, take legal advice early. Dispensing rules for ordinary medicines are covered in our post on dispensing at the clinic under Schedule K.