Bio Spectrum — May 2017

Indian Pharmaceutical Association

(IPA), a body of major domestic

pharma firms, has hit out at the

government over drug price control

issue and asks whether the rule of

law for the sector has been followed.

Expressing concern about future

of the pharma industry in India,

IPA said pharma companies have

become a victim of “unbridled turf

war” between the Department of

Pharma and drug price regulator

NPPA. In a letter to Niti Aayog Vice-

Chairman Arvind Panagariya, the

IPA said the last couple of years have

been unsettling for the domestic

pharma industry due to “arbitrary

and imaginative” implementation of

the drug pricing policy.

The alliance, which has members

including major homegrown

companies such as Sun Pharma, Dr

Reddy’s, Lupin, Glenmark, Cipla

and Cadila, among others, further

questioned the government’s

measures “that do not help customers

nor the industry”.

“The industry is perplexed by

the propriety, not just legality,

of several recent decisions of the

government. It has begun to doubt

if the country follows rule of law for

the pharmaceutical industry,” IPA

Secretary General DG Shah said in

the letter. Hitting out at the turf war

between the Department of Pharma

(DoP) and the NPPA, the letter said it

has become a nightmare not because

the pricing policy is defective.

“The problems have cropped up

because of imaginative and arbitrary

implementation of the pricing policy

and unbridled turf war between the

government (DoP) and the regulator

(NPPA),” it said.

The Centre is taking steps to explore the benefit of

using genomic research for precision medicine,

the Lok Sabha was informed. “The Science and

Engineering Research Board under the Department

of Science and Technology (DST) has taken steps

to explore the benefit of using genomic research

for precision medicine approach,” MoS for Health

Faggan Singh Kulaste said in a written reply. He

said the department has sponsored various projects,

especially mapping the genes

responsible for a number of

non-communicable diseases

(NCDs), to strengthen and

promote genomic research.

“Studies are in

progress to delineate the

etiopathogenesis of various diseases, which will have

impact on early diagnosis and prevention. Apart from

this, extramural programmes have been initiated by

the DST for scientists in this area,” Kulaste said.

He said the Indian Council of Medical Research

(ICMR) has set up a task force on pharmacogenomics

in 2012 and has funded 11 projects between 2015 and

2017. The ICMR has also funded advance centre on
      genomics Type 2 diabetes while the health ministry is
      also running a national programme to check the rise
      of NCDs, the minister said. Precision medicine is an
      emerging approach for treatment and prevention of
      diseases that takes into account individual variability
      in genes, environment and lifestyle for each person.

Drug price regulator National Pharmaceutical Pricing

Authority (NPPA) has increased price of stents by

around 2 per cent effective April 1 after taking into

account wholesale price index. The prices of bare

metal stents have gone up to Rs 7,400 from the earlier

announced prices of Rs 7,260. Similarly, price of drug

eluting stent has increased to Rs 30,180 from Rs

29,600 earlier.

In February, NPPA brought

stents under price control and

capped ceiling price of coronary

stents at Rs 7,260 for bare metal

stent and Rs 29,600 for drug-

eluting ones. The corresponding

average MRPs before the price

control stood at Rs 45,100 and Rs

1.21 lakh respectively. NPPA has

also fixed ceiling price of 46 drug

formulations used for various

ailments including hepatitis B,

HIV and tuberculosis.

“NPPA has fixed/revised

ceiling prices of 46 scheduled

formulations of Schedule-I

under Drugs (Price Control)

Amendment Order,” the regulator said in a statement.

The government fixes the prices of essential drugs

based on the simple average of all medicines in a

particular therapeutic segment, having sales of more

than one per cent. Besides, it regulates the prices of all

other medicines, while companies are allowed to hike

prices of such drugs by up to 10 per cent in a year.

IPA questions drug pricing policy implementation

Govt explores benefit

of genomic research

for precision drugs

Stent prices up by

around 2 per cent

(^10) POLICY AND REGULATORY NEWS l (^) BioSpectrum | May 2017 | http://www.biospectrumindia.com