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Report of the Committee


Report of the Committee

1. Background

Indian Medical Association raised various issues such as the capping-off of the compensation for alleged medical negligence, assault on doctors, amendment in PC&PNDT Act and the Clinical Establishments Act It has also put forth its demand that non-MBBS and non-BDS doctors may not be allowed to prescribe medicines under modem system of medicine Consequent to the meeting of National President and Secretary General of IMA with Hon'ble Union Minister for Health & Family Welfare, a Committee was constituted under the chairmanship of Additional Secretary (Health), Union Ministry of Health and Family Welfare to examine the issues raised by Indian Medical Association (IMA). The constitution of the Committee was as under-

  1. Joint Secretary (dealing with the subject), Ministry of Health & Family Welfare;
  2.  Joint Secret Ministry of Law & Justice;
  3.  Joint Secrets Department of Consumer Affairs:
  4.  Joint Secretary, ministry of Home Affairs:
  5. A representative from MCI:
  6.  A maximum of three representatives from IMA

2. As per the Terms of Reference, the Committee was to examine the following issues raised by the IMA and on the points impinging on these issues.

a) Frequent instances of assault on doctors and clinical establishments across the country and the need for a central Legislation for providing protection to the same.

b) Urgent amendments in the PC & PNDT Act to ensure that strict penalties are imposed only on actual act of sex determination or female feticide and not for clerical errors in the maintenance of registers etc. The IMA is also of the view that registration should be of ultrasound machine and not of doctors not doing pelvic ultrasound.

c) Single doctors establishments should be exempted from the purview pf the Clinical Establishments Act and the need for pre-registration inspection may not be there for those clinical establishments which already have entry level NABH accreditation and above.

d) Suitable amendments should be made in the Consumer Protection Act for capping the compensation amount as the current compensation practice, apart from being very high at times, was also tilted in favour of the persons with higher income.

e) The non-MBBS and non-BDS doctors should not be allowed to prescribe medicines under modern system and the other stream practitioners like AYUSH doctors etc. should not be allowed to practice through bridge courses and through government orders.

  1. Secretary, M/O Home Affairs, Secretary, D/o Consumer Affairs, Secretary, M/O Law & Justice of the Government of India were requested to depute Joint Secretary level officers as Members of the Committee, secretary, Medical Council of India (MCI) deputed a nominee to the committee.  National President of IMA, were informed to be part of the committee and to attend the meetings as scheduled.

 

All the issues were discussed in detail and the stakeholders were asked to submit their comments. IMA also gave its comments. The comments of Medical Education Division, ECH Division and the Division dealing with clinical establishments Act in MoHFW were also sought and considered. The comments from Ministry of Home Affairs, Department of Consumer Affairs and Ministry of Legal Affairs were also sought.

 

  1. Discussion and Recommendations

 

The Committee examined all the submissions made by different stakeholders. It took all the comments and facts on record. On the basis of facts, records and submissions, the committee decided to make the following recommendations:-

 

 

Sl. No.

Terms of Reference 

Recommendations

1.

Frequent instances of assault on doctors and clinical establishments across the country and the need for a Central Legislation for providing protection to the same.

(1)The issue was discussed in detail in the meetings on 8/12/2015 and 5/1/2016. Therefore, comments were also sought from different stakeholders. M/o Home Affairs commented that Indian Penal Code (IPC) is a general comprehensive code intended to cover all substantive aspects of criminal law and code; criminal procedure is the main legislation or procedure for administration of substantive criminal law in India irrespective of category of work etc. The IPC does not provide punishment for offences committed against any specific category of professionals. The offence which is otherwise covered in the IPC/Cr. PC committed against a doctor/clinical employee would automatically get covered under IPC/Cr. PC.

IMA in its last submission indicated that States have enacted laws or issued ordinances to protect medical practitioners.

Both Law & Order and Health are State subjects and the conditions differ across the county on these matters. The provisions of IPC and Cr. PC are sufficient as far as the protection of property or life of any professional in India is concerned  The Committee maintained that essentially the enforcement of these provisions was most crucial.

Committee accordingly recommends as follows:

  1. Ministry of Health & Family Welfare in view of the perceptible need will suggest all the state governments which do not have a specific legislation to protect doctors/health professionals to consider enacting one.
  2. Ministry of Health & Family Welfare shall emphasize to all State Governments to strictly enforce the provisions of special legislation wherever they exists and/or enforce the IPC/Cr. PC provisions with vigour.
  3. IMA reiterated that other, other than the aforesaid suggestions, it is of the considered opinion that modality of the central enactment alone shall dispense the desired goal.

 

2.

Urgent amendments in the PC&PNDT Act to ensure that strict penalties are imposed only on the actual act of sex determination or female feticide and not for clinical errors in the maintenance of registers etc. The IMA is also of the view that registration should be of ultrasound machines and not of doctors not providing pelvic ultrasound..

 

 

(2)IMA’s suggestions regarding various provisions of PC & PNDT Act were discussed in detail. The comments of the concerned Divisions of the Ministry of Health & FW were also considered. The Committee recommends as follows:

  1. Ministry of Health & Family Welfare shall recommend appropriate amendments to the governing rules whereby except for female foeticide, no other error/mistake will be construed as criminal offense and remainder shall be governed by commensurate graded improbable punishment.
  2. Ministry of Health & Family Welfare shall  ensure that the Delhi High Court Order occupies the space as of now in relation to ensuring that doctors not doing pelvic ultrasound are not subjected to provisions of PC&PNDT Act.

 

3.

Single doctors establishments should be exempted from the purview of the Clinical Establishments Act and the need for pre-registration inspection may not be there for those clinical establishments, which already have entry level NABH accreditation, and above

(3)a. IMA also raised the demand of deletion of the City Police Commissioner/SSP/SP or his nominee from the District Registering Authority (DRA). IMA also wanted the inclusion of a representative each from the professional associations of modern system of medicines and AYUSH in DRA. These demands were discussed and comments were obtained from the relevant stakeholders as the conditions differ across the county on these matters. The Committee recommends a suitable amendment in the Central Rules to reconstitute the District Registration Authority so as to delete the provision of membership of City police commissioner/SSP/SP or his nominee in the DRA and the inclusion of a representative from Indian Medical Association as well as AYUSH.

 

(b). IMA  is of the considered opinion that a single doctor clinic has to be excluded from the definition and ambit of the word clinical establishment as  mentioned in Section 2 (c)  of Clinical etablishemenbt (Registaation & Regulation) Act 2010.The definition of the word Clinic may be derived from Haryana Clinical Establishment (Registration & Regulation) Act 2014 which is defined under Section 2 (e) of Haryana Clinical Establishment (Registration & Regulation) Act 2014, which is defined as under:

 

“Clinic” means, a place used or intended to be used for consultation, diagnosis and treatment of a person as Outdoor Patient Department by single registered medical practitioner”.

 

 (c). The Committee noted that the Indian Medical Association does not have any objection to the registration of NABH (including entry level) accredited clinical establishments under the Clinical Establishments Act. However, the Association is of the strong view that NABH (including entry level) accredited establishments may not be subjected to inspection. The Committee after detailed deliberations noted that in terms of Section 25 of the Act, clinical establishments are required to submit evidence of having complied with the prescribed minimum standers in a manner as may be prescribed. The Committee considers that the fact that the clinical establishment is NABH (including entry level) accredited, could be taken as an evidence of compiling with the prescribed standards. Further, Section 33 (1) of the Act vests a discretion to cause an inspection or, an enquiry in respect of any registered clinical establishments, its buildings etc. The committee, therefore recommends that in the exercise of such discretion, inspection in respect Clinical establishments with NABH (including entry level ) accreditation need not be insisted upon in each case and the rules may be amended accordingly.

 

As per Section 45 of the Act, if any clinical establishment is registered under any other existing law requiring registration such as PC&PNDT Act, the clinical establishments are also required to apply for registration under the Clinical Establishments Act (CEA). While there can be no exemption from registration under the CEA, it is recommended that concerned Divisions of MoHFW will explore the possibilities  of bringing in legislative changes for single window registration.

 

(d). The Clinical Establishments Act provides for provisional and permanent registration At the time of provisional registration, there is no inquiry or inspection. As per Section 14(4) of the Act, existing clinical establishments can apply for permanent registration within a period of two years after notification of minimum standards. Thus, the clinical establishments have sufficient time to upgrade the facilities, if required, to meet the minimum standards. The registration, with the government increases consumers confidence and brand value of the clinical establishments.

 

In so far as the penalty for non registration is concerned, it is applicable to the one running the clinical establishment and not necessarily to a doctor as per Section 41 (1.)

 

As far as penalty for running a clinical establishment without registration is concerned, Section 41 (5) clearly stipulates that while determining the quantum of monetary penalty, the authority shall take into account the category, size and type of the clinical establishments and local condition of the area in which establishments is situated.

e. The Committee recommends that IMA may set up a standing committee which would periodically suggest changes in the standard treatment guidelines/advisroy under the clinical establishments act with justification. These suggestions would be examined by the Central Government in consultation with the other stakeholders viz. State Governments (health being a stable subject) and Standard Treatment guidelines would be revised annually, if the need be.

 

f. The Committee recommends that the position of the Rule 9(ii) of the clinical establishments Rules can be considered to be changed to the extent that central government should specify the list of procedures and costing templates while actual determination of the range of rates could be left to the State Governments who can take into consideration the relevant facts while deciding upon range of rates for their respective States in consultation with relevant stake-holders including Indian Medical Association.

 

 

4.

Suitable amendments must be made in the Consumer Protection Act for capping the compensation amount as the current compensation practice, apart from being very high at times, is also tilted in favor of those with higher incomes

The suggestions given by IMA were discussed and comments were also sought from different stakeholders. During the discussion it was felt that reasonable fee is  charged by the doctors, and accordingly the compensation should be reasonable. The IMA proposed that a formula mentioned in Rule 122 (B) for Drugs and Cosmetics Rules may be used to ascertain the quantum of compensation is decided on the basis of Consumers Protection Act, which is under the Ministry of Consumer Affairs. Hence, any change would be carried out by them. The proposal submitted by IMA is recommended by the Committee for appropriate amendments in the Consumer Protection Act by the Ministry of Consumer Affairs.

 

 

 

5.

The non- MBBS and non-BDS doctors should not be allowed to prescribe medicines under the modern system and the other stream practitioners like AYUSH doctors, etc. orders

The representatives of IMA stated that certain State Governments have allowed AYUSH doctors to prescribe certain allopathic drugs/medicines. Health is a state subject. As far as the existing legal position is concerned, as per the IMC Act, only those who are in the IMC/SMC register can prescribe allopathic drugs/medicines.

 

Further, as per section 2-C(I) of the clinical Establishments Act, only clinical establishment of a recognised system of medicines can be registered. This Act also seeks to register and regulate the clinical establishments which have been set up and managed by the qualified professionals only.

 

 

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