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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: 

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. 

Partnership options refer to the different modalities utilised by stakeholders of the National TB Elimination Programme (NTEP) to engage with a private-sector partner to improve the availability and quality of service delivery for TB patients.

The table below shows the partnership options that are currently available. The programme manager, based on the findings of the needs assessment, can identify the relevant partnership options that they can implement in their region.

Table: Available Partnership Options and their Scope of Services

The private-sector health facilities have experts and infrastructure to manage TB cases. Under the direct engagement partnership model, the programme manager directly engages private-sector health facilities which provide TB services to ensure that standards of TB care reach all the patients in that facility.

In a region where there is no dedicated Patient Provider Support Agency (PPSA), the National TB Elimination Programme (NTEP) can directly empanel and engage a private/ corporate/ trust hospital and designate them as “TB Treatment Centres”.

The System for TB Elimination in Private Sector (STEPS) model evolved as a solution to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in India (STCI). STEPS is envisioned as an equal partnership between the public and private sectors for the benefit of society with TB elimination as the outcome.

The primary objective of STEPS is to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in both sectors to all citizens in a patient-centric manner.