The recent Niti Aayog’s Three
Year Action Agenda, 2017-18 to 2019-20 on Access
to Medicines (pages 144-145) is rather disturbing. “A balanced
approach towards regulation is needed for achieving the twin objectives of
access to effective medicines and a strong pharmaceutical industry,” so
says the Agenda document. “There is a trade-off between lower prices on
the one hand and quality medicine and discovery of breakthrough drugs on the
other. It is therefore recommended that the Drug Price Control Order may be
delinked from the National List of Essential Medicines.”
Is this is one among the many instances of the government’s
double-and-multi-speak? The Prime Minister and his Minister of Health and
Family Welfare speaking in one voice and the Niti Aayog in another! Was the PM
trigger-happy in his muscular tweets (as given below), thrice inside 5 minutes,
conveying his concern for the poor, the wretched of the earth? Or was he being
plain naïve and didn’t (and still doesn’t) know the issues behind it?
The poor must have access to quality and affordable
healthcare: PM @narendramodi in Surat
10:45 AM – 17 Apr 2017
10:45 AM – 17 Apr 2017
After assuming office, mechanisms were put to bring down
prices of medicines even if that meant pharma companies are unhappy with us: PM
10:47 AM – 17 Apr 2017
There are powerful people who are unhappy with me. But, my
commitment is to provide affordable healthcare for poor and the middle class:
PM 10:50 AM – 17 Apr 2017
The PM seems to have jumped the gun to carry out this – to
use one of today’s plenty “Modi-ism” – “surgical operation” on branded
medicines. Discerning citizens even with a nodding acquaintance with
politicians’ utterances take such loud protestations with a pinch of salt; in
every welfare activity, we are wont not to be taken in by the government's
pro-people motivations. Peel off the epidermis and the hypodermis will reveal
the true intent! Mostly people's welfare is shambolic, it makes for good
sloganeering, loud and majestic in its decibel, and to win brownie points at
the hustings where voters unthinkingly swallow whatever is dished out. Frankly,
no government (least the present one) can afford to ignore the big business
houses in our emerging economy's electoral processes. Political pragmatism
tells them that their acts must be craftily done with the sheen to help the
poor. In the cacophony the common man suffers – or lives in a fool’s paradise
till he loses the visions of this “paradise” – while the big pharma companies,
druggists and hospitals remain as unfazed and unflustered as ever.
That said, it might sound paradoxical to say that while
generic drugs should be the order of the day, in today’s India few generic
drugs pass the quality test. The 1980s and 1990s was a time of the generic drug
“robber barons” thanks to poor laws and populist aspirations of the then
governments bent on low drug prices sans quality of drugs. Little wonder India though
placed 4th in global generic drug market, has earned the ignominy of
manufacturing 75% of world’s counterfeit generic drugs, soaring high above
Egypt with 7% and China with 6%.
To be fair to the government, it has in April 2017 made changes
to the Drug and Cosmetics Act (1940) making it mandatory for genetic drug
manufacturers to submit Bioequivalence (BE)/Bioavailability (BA) study reports
for approval as against the earlier practice of submitting the BE/BA reports
for genetics of patented drugs in the first 4 years of introduction. Nothing
more is asked of them, thus making it a field day for genetic drugs to flood
the market. Once in an indigo moon the finished drug was submitted for testing
at the Central Drugs Standard Control Organization (CDSCO). No wonder barely 0.01%
of the genetic drugs in the Indian market are tested for its potency and
efficacy. In effect, the amendment to the Drugs and Cosmetics Act (1940) is a
welcome development. But the issue now is one of regulation and implementation.
Anyone who has worked in the government knows its innards. The system is so
apathetic and opaque and convoluted that a complaint of poor/inadequate potency
will keep meandering about in the corridors of government Bhavans; the
callousness of our Brother Babus is phenomenal!
There doubtless is the need to increase the number of test
labs all over the country in government medical colleges, increase the number
of pharmacists/pharmacologists, put a strict testing process in place, and go
fully transparent with test results by uploading them in public domain. Any
complaint from a consumer must be attended with a sense of immediacy and the
same too put out on the website. But will the government bite such “dangerous”
transparency that will jeopardize big pharma companies’ interest? I doubt if
this will ever happen, given this government’s poor track record in refusing to
appoint a Lokpal three years after coming to power! And to expect the
government to seed a billion Lokpals to oversee is a pipedream! We are then
back to square one despite the recent amendment to the Drug and Cosmetics Act
(1940).
Large pharmaceutical companies invest huge money in
developing a new drug; the amount could be more than US$ 2-3 billion. Naturally
they will like to get return on investment – through patent and royalty. India
too seeks big bang R&D in drugs and Indian firms are interested. This
explains why the government is speaking with a forked tongue: while the PM and
his Ministers speak about mandating generics, the Niti Aayog suggests “a
trade-off between lower prices on the one hand and quality medicine and discovery
of breakthrough drugs on the other”. And recommends that “the Drug Price
Control Order may be delinked from the National List of Essential Medicines”
Essential medicines, says the World Health Organization
(WHO) are “those drugs that satisfy the health care needs of the majority of
the population; they should therefore be available at all times in adequate amounts
and in appropriate dosage forms, at a price the community can afford”. While
National List of Essential Medicines (NLEM) is a list of essential medicines in
India prepared by the Ministry of Health & Family Welfare,the Drug Price
Control Orders (DPCO) are issued by the Government under section 3 of the
Essential Commodities Act, 1955, to enable the Government to put a ceiling
price for such essential and life saving medicines and ensure that these
medicines are available at a reasonable price to the general public.
What’s puzzling is the furtive effort of Niti Aayog to
defeat the PM’s noble intentions by equating (in effect) lower prices of drugs
under NLEM (and hence under DPCO) with poor quality. The digital magazine The
Wire in a well-researched piece has shown how there has been an effort
on the part of the PMO with Niti Aayog, Ministry of Health & Family
Welfare, Department of Industrial Policy & Promotion, and Department of
Pharmaceuticals on board to scupper efforts at popularizing generic drugs and
instead hold a brief for multinational pharma firms. Their move to “trade-off”
is to delink DPCO from the NLEM will result in soaring of prices of essential
drugs. It also runs counter to the government’s affidavit in the Supreme Court
and the Minister of Health and Family Welfare’s reply in the Rajya Sabha. The
move is blasphemous and highly condemnable. But such are the ways how
intellectual dishonesty is sown in Indian system!
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