CHO-M7: Private sector Engagement

As a public health responsibility to prevent transmission of TB infection and development of drug resistance it is essential to engage both the public and private sectors for effective TB prevention and control. A total of seven standards related to Public Health Actions (PHA) (Standard 12 to Standard 18) have been mentioned in the Standards for TB Care in India (STCI)-2014.  All patients notified from the private sector also need to be offered all public health actions. 

This could be achieved in collaboration with the local public health services and/or other agencies.  

1) Provide Access to Correct and Complete Diagnosis for Private Sector Patients

• In this regard all private providers must be sensitized, and their capacities must be built with respect to early diagnosis, prompt referral for sputum smear examination to the National TB Elimination Programme (NTEP) diagnostic facilities / NTEP accredited private labs.
• All private providers and chemists/pharmacists must mandatorily notify the TB patients to the local health authorities – District Health Officer / District TB Officer.

2) Provide Support for Treatment Adherence 

• A treatment support plan must be developed at the time of treatment initiation for all patients in the private sector too, in mutual consultation with patient and private provider.
• All patients receiving treatment from the private sector must also be eligible to receive counselling services and upon consent, home visit counselling sessions (or at the location convenient to the patient) may be provided to patients and their caregivers under the NTEP’s Public Private Mix (PPM) or in association with partner agencies providing counselling services under NTEP.
• Any instance of treatment interruption must be reported at the earliest through Ni-Kshay.
• The patients may also be linked to Ni-Kshay call-centers for adherence support. 
• The NTEP has also partnered with Patient Provider Support Agency (PPSA) / Patient Provider Interface Agency (PPIA) wherein vouchers were provided to private sector TB patients for utilizing subsidized TB diagnostic and follow up investigation services and can be scale up in high burden districts across the country with support from state governments/ Corporate Social Responsibilities (CSR) agencies.

4) Contact Tracing and TB Preventive Treatment

• All private providers must hold a responsibility to ensure that persons in close contact with patients who have infectious tuberculosis are evaluated at the earliest and managed in line with NTEP recommendations. The district health officers and district TB officers must be responsible to ensure this is being done on a regular basis.
• Eligible contacts should also be counselled for initiation of TB preventive treatment.

5) Linkage to Social Welfare and Protection

• Upon notification by the private provider and initiation of appropriate TB treatment, all patients seeking treatment under the private sector become eligible to receive direct benefit transfer (DBT) under the government of India's Nikshay Poshan Yojana (NPY)
• In districts where PPSA is available, PPSA staff may perform the linkage of private sector patients to DBT services and in districts where PPSAs are not available, the TB Health Visitor/ Senior Treatment Supervisor (STS) needs to undertake the public health action under the supervision of the PPM Coordinator.
• The patients may also be guided and linked to various other social protection and welfare schemes available under central and state governments. The partner agencies with expertise in referral linkages shall help the NTEP in achieving this.

6) Liaison with Professional Bodies

• Professional bodies such as Indian Medical Association and Indian Pharmaceutical Association must be involved for advocacy regarding the services available under public health actions of NTEP for the private patients.
  

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, GoI, 2021.
• Mandatory TB Notification Gazette for Private Practitioners, Chemists and Public Health Staff, RNTCP, 2018.
• Notification of TB Cases: Amendments, MoHFW, GoI, 2015.
• TB Notification Order, MoHFW, GoI, 2012.
• National Strategic Plan for Tuberculosis Elimination 2017-2025, RNTCP, CTD, MoHFW, 2017.
• Standards for TB Care in India, WHO, 2014.

Assessment

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