Notification, 2018

Text

Reproduced from the document India Code holds for this instrument. The Gazette prints Hindi and English side by side and this is the English; the Department's own PDF remains the authority.

EXTRAORDINARY

PART I—Section 1

PUBLISHED BY AUTHORITY

ता�र : ................................................. �दनांक: ....../......./...... ता�र : ................................................. �दनांक: ........ /......./......

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 16th March, 2018 F.No. Z-28015/2/2012-TB.—Whereas, the Central Government is satisfied, that tuberculosis is a dangerous epidemic disease, threat to life and is a major public health problem accounting for substantial morbidity and mortality in the country. Early diagnosis and complete treatment of tuberculosis is the corner-stone of tuberculosis prevention and control strategy. Further, inappropriate diagnosis and irregular or incomplete treatment with anti-tubercular drugs may contribute to complications, disease spread and emergence of drug resistant tuberculosis.

2. Whereas, to ensure proper tuberculosis diagnosis and its management in patients and their contacts and to reduce tuberculosis transmission and further to address the prob- lems of emergence and spread of Drug Resistant-Tuberculosis, it is essential to collect complete information of all tuberculosis patients.

3. Now, therefore, in the interest of public health to control and prevent the tuberculosis disease, the Central Government, specify the following measures, namely:-

(1) The Healthcare Providers, termed as Clinical Establishment henceforth; shall notify every tuberculosis patient to local Public Health Authority, namely, District Health Officer or Chief Medical Officer of a District and Municipal Health Officer of urban local bodies in whatever way they are known; or their designated District Tuberculosis Officers in a format as specified in, -

(i) Annexure-I by the Medical Laboratories;

(ii) Annexure-II by the Medical Practitioners.

(2) All Pharmacy, Chemist and Druggist dispensing anti-tubercular medicines, shall notify respective tuberculosis patients along with details of medicines as per An- nexure-III and maintain a copy of prescription - Annexure IV, the treating Medical Practitioner as per Schedule H1 of the Drugs and Cosmetics Rules, 1945; and shall furnish the same either electronically or in hard copy, to the Nodal Officer of the District or any Officer authorised by Nodal Officer.

(3) Considering the importance of patient support needed for complete and appropriate treatment of all tuberculosis patients are encouraged to self-notify themselves with their own details and that of treating medical practitioners.

4. Definitions: For the purpose of this notification, unless the context otherwise requires, the expressions -

(i) ‘Tuberculosis patient’ means a patient diagnosed with at least one clinical specimen positive for acid fast bacilli, or culture-positive for Mycobacterium tuberculosis or rapid diagnostic molecular test positive for tuberculosis, or any other tests recommended by Ministry of Health and Family Welfare, Government of India or a patient diagnosed clinically as a case of tuberculosis, without microbiologic confirmation, and initiated on anti-tubercular drugs.

(ii) ‘clinical establishment’ shall have the meaning assigned to it, clause (c) of Section 2 of the Clinical Establishment Registration and Regulation Act, 2010, (23 of 2010).

5. List and contact details of the concerned State Tuberculosis Officers and District Tuberculosis Officers, shall be regularly updated by the Central Tuberculosis Division, in the Ministry of Health and Family Welfare, Government of India and made available on www.tbcindia.gov.in and https://nikshay.gov.in; who are responsible for implementation of tuberculosis notification in their respective areas of jurisdiction and shall ensure that following action is taken by local public health staff of general health system of rural or urban local bodies, on receipt of information on tuberculosis patient notification through hard copy or through online application named Nikshay:

(1) patient home visit as per convenience of patient;

(2) counselling of tuberculosis patient and family members;

(3) treatment adherence and follow up support ensure treatment completion;

(4) contact tracing, symptoms screening, evaluation of tuberculosis symptomatics and offering isoniazid chemoprophylaxis to eligible contacts;

(5) offering HIV counselling and testing, drug susceptibility testing;

(6) linking with available social welfare and support schemes.

6. Secured web portal like https://nikshay.gov.in shall be made available by the Central Tuberculosis Division to all practitioners, clinical establishments, pharmacies, chem- ists, druggists and patients for online submission of information.

7. The information on tuberculosis notification received by Public Health Staff, shall be used only for extending the care and support, take appropriate public health action as mentioned in paragraph 5 above; including financial and non-financial incentives to patients, like free drugs and diagnostics, screening for co-morbidities, drug susceptibility test- ing, information technology based treatment adherence support system for improving quality care, etc., and providing feedback to the respective treating medical practitioner: pro- vided that the confidentiality of the individual identity of the tuberculosis patients shall be maintained.

8. Tuberculosis patients notified from Pharmacies, Chemists and Druggists and those patients self-notified, shall be contacted and verified by Public Health Authority or their authorized representative.

9. For tuberculosis patients notified from Medical Laboratory, Chemist and self-notification by tuberculosis patient, staff of public health system will gather information to complete notification which include basis of diagnosis, site of disease, history of anti-tubercular treatment and classify type of tuberculosis patient.

10. These measures shall prevail over the earlier measures issued vide order F.No. Z-28015/2/2012-TB, dated the 7 th May 2012 and its amendment dated the 23th July 2015.

11. The Clinical Establishment, Pharmacy, Chemist and Druggist, failing to notify a tuberculosis patient to the nodal officer, as mentioned in paragraph 3 above and local pub- lic health staff of general health system of rural or urban local bodies, not taking appropriate public health action on receiving tuberculosis patient notification as per paragraph 5 above, may attract the provisions of sections 269 and 270 of the Indian Penal Code (45 of 1860), as the case may be, which are reproduced below: “269. Negligent act likely to spread infection of disease dangerous to life. - Whoever unlawfully or negligently does any act which is, and which he knows or has rea- son to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.

270. Malignant act likely to spread infection of disease dangerous to life. - Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.” ARUN KUMAR JHA, Economic Adviser * Mandatory Laboratories include those Health Establishments carrying out any of the RNTCP endorsed TB diagnostics Signature:……………………………………… Date: …../……./…… Sr.

No.

Name of TB Patient (surname first) Father / Husband’s name Age (yrs) Sex (M/

F/O)

GoI issued identification number Complete residential address PIN number Patient Phone number Date of TB Diag- Date of sputum collection Date of result Type of Test result (smear mi- croscopy positive / culture posi- tive / MTB on LPA / MTB on Xpert / MTB in FNAC / TB on His- topath/ DST DST results for each drug tested (R=resistant / S=sensitive/NA=not available) Rif, INH, SM, EMB, Ofx, Km, Eto, Cipro, Capr, etc.

TB Notification reporting format for Medical Laboratory Period of reporting: From …../……./…… To …../……./…… Name of the Laboratory :……………………………………………………… Health Establishment code for TB Notification Registration Number:………………………………… Telephone (with STD):……………………… .……………/…………… Mobile number:………………………… Complete Address: ……………………………………………………………………………………………………….……… Annexure II TB Notification reporting format for Period of reporting: From …../……./…… To …../……./…… Name of the health facility / practitioner :…………………………………………(single/Multi) Health Establishment code for TB Notification Registration Number:………………………………… Telephone (with STD):………………………… ……………/………… Mobile number:………………………… Complete Address: ……………………………………………………………………………………………………….……… * Mandatory Private practitioner / Clinic (single) will include any Health Establishments where TB cases are treated or diagnosed clinically / radiologically and the medical services are pro- vided by single medical practitioner.

Hospital / Clinic / Nursing Home (multi-practitioners) will include any Health Establishments where TB cases are treated or diagnosed clinically/radiologically & medical ser- vices are provided by more than one practitioner.

Signature:……………………………………… Date: …../……./…… Sr.

No.

Name of TB Patient (surname first) Father / Husband’s name Age (yrs) Sex (M/

F/O)

GoI issued identification number * Complete residential address PIN no.

Patient Phone number Date of TB Diagnosis Date of TB treatment Site of Disease (P /EP)* Patient Type (New TB case/ Recurrent TB case/ Treatment change) * Basis of diagnosis (Smear microsco- LPA/ FNAC/Histo- Weight in Kg.

Drugs and dosages (in mg) Other (specify) Annexure II TB Notification reporting format for Medical practitioners / Clinics/Hospitals/Nursing homes Period of reporting: From …../……./…… To …../……./…… Name of the health facility / practitioner :…………………………………………(single/Multi) Health Establishment code for TB Notification Registration Number:………………………………… Telephone (with STD):……………………… ……………/………… Mobile number:………………………… Complete Address: ……………………………………………………………………………………………………….……… Pa- tient ID Pa- tient home visit Done (Y/N) If Yes, done by Pa- tient coun- seling Done (Y/N) Type of treat- ment adher- ence (DOT/

SMS/

eo box/

SAT)

Status of patient (regu- lar/ Not regu- lar) Month at which FU examina- tion done Status at FU exam- ination Clinical improve- ment No. of con- tacts No. of contact tomatic No.

found to have TB among contact No. of con- tacts initiat- ed on treat- ment No. of contacts offered chem- oprophylaxis HIV test- ing of- fered Pos) DST offered resistance /RIF sensi- tive/ Indetermi- nate) Treatment Outcome RC) This information on page 2 is to be submitted during treatment and after treatment completion with sos updation in Nikshay with public health action support by local public health staff.

Signature:……………………………………… Date: …../……./…… Annexure III TB Notification reporting format for Pharmacy, Chemist & Druggist Period of reporting: From …../……./…… To …../……./…… Name of the Reporting (pharmacy) :……………………………………………… Telephone (with STD):…………………………………… * Mandatory ** Not mandatory Signature:……………………………………… Date: …../……./…… For each notified patient the prescription details on drugs prescribed and drugs dispensed should be mentioned with dosages, formations and duration and Published by the Controller of Publications, Delhi-110054. Sr.

No.

Name of TB Patient (surname first) * Father / Husband’s name Age (yrs)* Sex /Transgender) ** GoI issued identification number * Complete residential address PIN no* Patient Phone number Date of TB Date of TB treatment initiation ** Date of Date of Dispensing Number of Days for which Medicines Name of treating medical practitioner (Prescriber) * Address & Registration no. of treating medical prac- titioner

SARVESH

KUMAR

SRIVASTAVA

SARVESH KUMAR

SRIVASTAVA

Provisions this notification answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Drugs and Cosmetics Act, 1940