DR-TB HIV Coordinator: Regulations

TB is a notifiable disease in India, and TB notification has been made mandatory at the point of diagnosis since May 2012. This means that when a case of TB is diagnosed and/or put on treatment it is to be reported to the  NTEP.

• Every healthcare provider, i.e., clinical establishments run or managed by the Government (including local authorities), private or NGO sectors and/or individual practitioners, need to notify diagnosed or treated TB patient’s. 
• Reporting is to be done on the online reporting system called Nikshay and should include details of patient identification, and TB diagnosis.
• This, apart from enabling essential public health actions such as Treatment initiation, and Contact Tracing, chemoprophylaxis, but also enables provisions of Direct beneficiary transfer for Nikshay Poshan Yojana

Points to Note:

As per MCI code of ethics a registered medical practitioner giving incorrect information on his name and authority about notification amounts to misconduct and such a medical practitioner is liable for deregistration. It is the duty of the registered medical to divulge this information to the authorized notification official as regards communicable and notifiable diseases. 

Resources

• TB Notification Letter from GoI, 7 May 2012.
• TB Notification Amendment, 21 July 2015, MoHFW.

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:

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.

Resources

• Rules for Selling of Drugs Under Schedule H1, Press release by MoHFW, 2013.
• The Drugs & Cosmetics Act and Rules, Ministry of Health & Family Welfare, Government of India, 2016.
• Frequently Asked Question on Gazette on Mandatory TB Notification for Chemists/ Pharmacies, Central TB Division.

Assessment