Dr KK Aggarwal
Recipient of Padma Shri
The chairman of National Pharmaceutical Pricing Authority (NPPA), Drugs Controller General of India (DCGI) have been transferred and Directorate General of Health services (DGHS) has been asked to
go on leave.
DCGI was responsible for streamlining all clinical trials and also fought
for banning fixed dose combinations (FDCs). NPPA had capped stent prices and
that of knee implants. It was now exposing rate variations in disposables and
non-NLEM drugs and devices.
Transfers are no doubt a prerogative of the govt., but their timing is
inopportune. This move of the govt. may be misunderstood. We only hope
that these transfers were not under the influence of industry pressure.
This would only become clear when Dr S Eswara Reddy, who has been
appointed as the new DCGI, and the person who will be appointed NPPA chairman
would carry forward work on the issues raised by their predecessors.
What is also surprising is that the NPPA Chairman
has been asked to proceed on leave without assigning the work to a
chairman-designate making NPPA practically a functionless body as of today.
Let’s revisit the issues that the NPPA Chairman had
proactively raised, which probably led to his ouster from this job.
Recent alleged incidents of huge bills for treatment from the
relatives of deceased patients in private hospitals in Delhi-NCR have been the
cynosure of all eyes and have sparked outrage among the general public. The
large amounts have also led to their scrutiny by the regulatory authorities
following complaints from the families of the deceased patients.
NPPA is the government regulatory agency, which controls the prices of
pharmaceutical drugs and devices in the country. Following the complaints filed
by the families, NPPA asked for details of billing from these hospitals and
analyzed them as per four categories in a report vide File NO.
27(2)/2017-Div-III/NPPA, GOI, Ministry of Chemicals & Fertilizers, Dept. of
Pharmaceuticals, NPPA, dated 20.2.2018, which was put in public domain, as
follows:
- Scheduled
formulations based on NLEM 2015 (Schedule 1 of DPCO 2013) and under price
control
- Non-scheduled
formulations (not under price control and out of Schedule 1 of DPCO 2013)
- Consumables
not listed as drugs (neither under price control and nor under Schedule 1
of DPCO 2013)
- Medical
devices (neither under price control and nor under Schedule 1 of DPCO
2013)
The breakup of the total bill as per the various components was as follows:
|
|
Amount
|
%
|
|
Scheduled
formulations
|
2,84,295.71
|
4.10%
|
|
Non-scheduled
formulations
|
17.79,898.66
|
25.67%
|
|
Non-scheduled
devices (IV cannula, catheter, disposable syringes with/without needles)
|
1,05,525.00
|
1.52%
|
|
Consumables
(surgical masks, gloves, etc.)
|
6,63,175.06
|
9.56%
|
|
Diagnostic
services
|
10,78,792.00
|
15.56%
|
|
Cost
of procedures
|
7.91,912.00
|
11.42%
|
|
Consultation
& Medical supervision
|
8.82,432.00
|
12.72%
|
|
Equipment
charges
|
5.16.771.00
|
7.45%
|
|
Room
Rent
|
8,04,850.00
|
11.61%
|
|
Surgery
|
27,113.00
|
0.39%
|
|
Total
|
69,34,764.43
|
100.00%
|
Scheduled formulations constituted only 4.10% of the total bill. In
contrast, the total cost of non-scheduled formulations was 25.67% implying that
mostly non-NLEM drugs (non-scheduled branded medicines), which do not fall
under price control, were prescribed, the cost of which were exorbitantly high.
Hospitals are dictating the MRPs for institutional bulk purchase resulting in
profiteering on drugs and devices. “Industry, in order to get bulk supply
orders is in a way ‘forced’ to print higher MRPs as per ‘market requirements”,
says the report.
Consumables such as surgical masks, gloves etc. were nearly 10% of the
total bill and more than twice the expenditure on scheduled (essential) drugs
(4.10%). These consumables are outside the purview of the NPPA and are not “under
any kind of price control or monitoring of MRPs since these are not even listed
as ‘drugs’ under Drugs & Cosmetics Act”. So, their costs cannot be
regulated even in public interest. Patients were being overcharged for
consumables.
The cost of diagnostic services was nearly 16% of the total bill. The
hospital was also overcharging for tests and investigations as the charges were
higher than those provided by other independently run private centers.
About 50% of the total cost is the cost of drugs and devices and
diagnostics, which is not included in the ‘estimate’ given by the hospitals to
the patients and their families. “The total expenditure on drugs and
devices and diagnostics is substantially high (46%) and does not make part of
the publicized ‘estimate’ or ‘package’ (in case of implants) by the hospitals
in comparison to ‘procedures’ (11.42%), room rent (11.61%) etc. which are the
more visible components.”
In all this, the doctor consultation and medical supervision charges come
out to be a meager 12.72%.
What
this report reveals is that it is the hospitals, which mainly benefit from the
inflated MRPs and the profits wherefrom and not the manufacturers of the drugs
and devices and neither the doctors, in contrast to what is popularly
perceived.
But indirectly, doctors are responsible for it, for not raising a voice
against it. If they are aware that this is happening, they need to protest
against such practices. MCI Ethics Regulation 6.3 clearly says that it is our
duty to see that the patient is not exploited either by us or through us.
6.3 Running an open shop (Dispensing of Drugs
and Appliances by Physicians): - A
physician should not run an open shop for sale of medicine for dispensing
prescriptions prescribed by doctors other than himself or for sale of medical
or surgical appliances. It is not unethical for a physician to
prescribe or supply drugs, remedies or appliances as long as there is no
exploitation of the patient. Drugs prescribed by a physician or
brought from the market for a patient should explicitly state the proprietary
formulae as well as generic name of the drug.
The judgement of the Supreme Court
in the matter of Samira Kohli vs Dr. Prabha Manchanda & Anr on 16
January, 2008 also talks about the same as below.
“28. But unfortunately not all doctors in government hospitals are paragons
of service, nor fortunately, all private hospitals/doctors are commercial
minded. There are many a doctor in government hospitals who do not care about
patients and unscrupulously insist upon 'unofficial' payment for free treatment
or insist upon private consultations.
On the other hand, many private hospitals and
Doctors give the best of treatment without exploitation, at a reasonable cost,
charging a fee, which is reasonable recompense for the service rendered.
Of course, some doctors, both in private practice
or in government service, look at patients not as persons who should be
relieved from pain and suffering by prompt and proper treatment at an
affordable cost, but as potential income-providers/ customers who can be
exploited by prolonged or radical diagnostic and treatment procedures. It
is this minority who bring a bad name to the entire profession.”
The time has come for the self-regulation. If the hospital industry does
not self regulate, then the govt. will do so, which will be not without adding
penal provisions for such practices.
