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  • Schedule H-1 Regulation

    Learning Objectives

    What is Schedule H-1 Regulation, What are the Anti-TB drugs include in that - Detail, What are the obligation in chemist under this ..

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Under the Drugs & Cosmetics Rules 1945, drugs specified under Schedule H are required to be sold by retail on the prescription of a Registered Medical Practitioner (RMP) only.  At present, Schedule H contains 510 drugs.  

Recently, a new Schedule H1 has been introduced through gazette notification GSR 588 (E) dated 30-08-2013, which contains certain third and fourth-generation antibiotics, certain habit-forming drugs and anti-TB drugs.

 

These drugs are required to be sold in the country under the following conditions: 

(1) The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.

(2) The drug specified in Schedule H1 shall be labelled with the symbol "Rx" which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border:

“Schedule H1 Drug Warning:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.”

 

List of anti-TB drugs included in Schedule H1

 

  1. Ethambutol hydrochloride
  2. Ethionamide
  3. Isoniazid
  4. Levofloxacin
  5. Moxifloxacin
  6. Pyrazinamide
  7. Rifabutin
  8. Rifampicin

 

Obligations of Chemists with Regard to Sales of Anti-TB Drugs Under Schedule H1

 

  • Mandatorily keep a copy of the prescription of drugs covered under Schedule H1 in a separate record and such record should be maintained for three years and be available for inspection.
  • The supply of a drug specified under schedule H1 shall be recorded in a separate register at the time of supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such record shall be maintained for three years and be open for inspection (Annexure IV).

 

Table: Annexure IV – Schedule H1 Drugs Record Format; Source: Frequently Asked Questions on Gazette on Mandatory TB Notification for Chemists/ Pharmacies. tbcindia.gov.in.

Sl. No: Date

Name of doctor/ prescriber

Address & Reg. No:

Name of patient & address Name of drug Batch number Expiry Quantity sold Bill no.
                 
                 
                 

 

 

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Assessment

Question​ Answer 1​ Answer 2​ Answer 3​ Answer 4​ Correct answer​ Correct explanation​ Page id​ Part of Pre-test​ Part of Post-test​
Schedule H1 drugs can be sold without the prescription of a registered medical practitioner. True False     2

Schedule H1 Drug Warning:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.”

  Yes Yes

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