THE TIMES OF INDIA, NEW DELHI SATURDAY, FEBRUARY 18, 2017 13TIMES NATION

New Delhi: In a warning tocompanies trying to create anartificial shortage of stents inthe market following a pricecap on the medical devices,the National PharmaceuticalPricing Authority (NPPA) hasasked state drug controllersto use their search and sei-zure powers — provided un-der Drug Price Control Order(DPCO) 2013 — to ensure thereis no shortage in the market.

Separately, the regulatorhas also written to the healthministry and department ofpharmaceuticals to ensurecompliance. The regulatorhas asked the government toinvoke Para 30 of the DPCO inpublic interest for stentswhich will enable the govern-ment to direct any manufac-turer to increase productionand supply to ensure there isno shortage of stents.

“It has also been informedto the NPPA that some manu-facturers/importers/distrib-utors are trying to create arti-ficial shortage of stents. NPPA

has advised all state govern-ments and state drug controll-ers to proceed under Para 30 ofthe DPCO, 2013, if required,”an office memorandum issuedby the regulator said.

Under Para 30 of the DPCO2013, any designated officer ofthe government, either be-longing to state or Centre, canenter any premises andsearch or seize stents any-where in the trade channel inorder to fully implement theNPPA’s order.

Earlier this week, NPPAcapped prices of bare metalstents at Rs 7,260, whereasboth drug eluting stents(DES) and biodegradablestents will now cost Rs 29,600.“We are taking all possiblesteps to ensure there is noshortage of stents and that

consumers are not over-charged,” pharma secretaryJai Priye Prakash said.

He added that any viola-tion of the order will be puni-shed under the Essential Com-modities Act or under provi-sions of DPCO. “The puni-shment will vary dependingon the extent of violation,” hesaid. The penalty can varyfrom cancellation of manufac-turing or import license toblack listing of a company.

Under DPCO, there are al-so provisions for penaltywhich includes recovery ofovercharged amount alongwith a 15% penalty.

The NPPA has also askedstent manufacturers to sub-mit a report on “price revi-sion compliance along withevidence” by March 1.

NPPA Tries ToFoil Artificial

Shortage

Most patients who un-dergo angioplasty andprocedures involving

stents have insurance andclaim reimbursement. Insur-ance companies thereforehave all billing data. We aretrying to tap that data to moni-tor the situation,” a senior National PharmaceuticalPricing Authority (NPPA) of-ficial told TOI.

While hospitals and car-diologists were found earningmost of the margins on stents,up to 650% in some cases,there are concerns that hospi-tals will find ways to maintainprofits under other heads ofmedical expenditure.

“We are taking all possiblesteps to ensure complianceand to ensure that stent pricecapping benefits are passedon to the patients and no artifi-cial shortage is created,”NPPA chairman BhupendraSingh said. The data is also ex-pected to point towardschanging trends providingleads to authorities for fur-ther investigation or action incase of established violation.

For instance, if there is asudden spike in bed charges,the billing data is likely topoint at it. Or if the overallbilling does not come down asa result of price control forstents, it will prompt author-ities to investigate.

NPPA has already askedhospitals, nursing homes andclinics performing cardiacprocedures using stents to dis-close separately the cost of thestent while billing a patient.

Apart from IRDA, thepharma pricing authority isalso in talks with four to fivemajor health insurance pro-viders for billing data.

‘Trying ourbest to ensure

availability’�Continued from P1

Apprehensions of the Na-tional PharmaceuticalPricing Authority

(NPPA) about the creation ofan artificial shortage instents appear to have cometrue. Major stent companieshave been withdrawing themore expensive brands fromhospitals claiming that theyare doing it for relabelling,even though the NPPA hasclarified that relabelling isnot required. And hospitalshave been finding ways to notpass on the entire benefit ofthe price cut to patients.

Cardiologists in top hospi-tals confirmed that the moreexpensive stents of multina-tional companies are not avail-able anymore and were re-moved for “relabelling”. Manyhospitals have also been toldby companies that they cannotprovide the more expensivestents for the NPPA-set price.

Multinational stent com-panies and their associations,like the Medical TechnologyAssociation of India (MTaI),however, claimed that theyhave not withdrawn any prod-uct. They rubbished chargesof creating an artificial short-age saying there was “a delib-erate attempt to tarnish theimage of the companies”.

“The current hype aboutshortage is wrong and de-signed to create panic amongthe public to put pressure onthe government. Indian stentsare used in several Indian hos-pitals and are being exported toEurope and have been shown tobe as good as any other stents inthe market,” said Rajiv Nath of

the Association of Indian De-vice Manufacturers. “If theyare safe for Germans, I’m surethey are safe for Indians too.”

Even the not-so-expensiveimported stents, which arecurrently available, were be-ing sold in large corporate hos-pitals for Rs 90,000 to over Rs 1lakh prior to the price fixation.

A former director of a Pat-na-based private hospital thatis part of an all-India chainsaid the hospital used to chargeRs 90,000 for stents and a simi-lar amount for the procedure,adding up to Rs 1.8 lakh. How-

ever, if they have to reduce thecost of stents they will up thecost of procedures, he said.

“We have not received anycomplaints of shortage or over-charging so far,” DoP secretaryJai Priye Prakash said. He add-ed that the government and theregulator have taken severalsteps to ensure compliance.

The union health secretaryexpressed its inability to actagainst hospitals that flout theNPPA order as health is a statesubject. However, the Maha-rashtra Food and Drug Admin-istration (FDA) has initiatedan informal survey to ensurecompliance and availability ofthe implants at hospitals.

“While the stakeholdersare working out some solutionswith the government, we willkeep a check on hospitals,” saidVinita Thomas, FDA’s actingjoint commissioner for GreaterMumbai. She added that the de-partment may send decoy pa-tients to hospitals, besidesstudying bills.

Makers, hospitalsconspire to fleecestent recipients

TEAM TOI

Lubna.Kably@timesgroup.com

Mumbai: Baba Ramdev’s Pa-tanjali Yogpeeth (a publiccharitable trust) has succeed-ed in its appeal before the In-come-tax Appellate Tribunal(ITAT), which has accepted itstax exempt status. The ITAT(Delhi bench) held that Yogaentails providing medical re-lief and camps also provideeducation, and that both ‘med-ical relief ’ and ‘imparting edu-cation’ fall within the mean-ing of charitable purpose, en-titling the trust to claim I-T ex-empt status under sections 11and 12 of the Income Tax Act.

“The finding of I-T author-ities that propagation of yogaby Patanjali Yogpeeth does notqualify as medical relief orimparting of education is notjustified,” stated the ITAT inits order dated Feburary 9.Even as the litigation settledby the ITAT, relates to the 2008-09, the ITAT has also referredto subsequent amendment inthe I-T Act, which came into ef-fect from April 1, 2016. Thisamendment specifically in-serted ‘yoga’ within the defini-tion of ‘charitable purpose’. Ifthe exempt status not been up-held by the ITAT, Patanjali

Yogpeeth would have been lia-ble to pay income tax. The totalincome of this trust is notbrought out in the ITAT order.

The ITAT also held thatcorpus donations aggregat-ing to Rs 43.98 crore receivedby Patanjali Yogpeeth, pre-dominantly for constructionof cottages under its Van-prasth Ashram Scheme(which provides accommoda-tion to those attending resi-dential yoga courses), werecapital receipts not liable toI-T. Such donations includedland donated, whose marketvalue was pegged by I-T au-thorities at Rs 65 lakh. In itsorder, the ITAT pointed outthat “Corpus donations arenot taxable, even in circum-stances where the trust is not

eligible for I-T exemption”. Various additions to the

trust’s income made by the I-Tauthorities, including a Rs 96lakh addition made for servic-es made by the trust to VedicBroadcasting in whichAcharya Balkrishnan, atrustee and close aide of BabaRamdev holds substantial in-terest were deleted by theITAT, on the ground that theI-T authorities had not under-stood the facts.

The ITAT also agreed withthe submissions made by thetrust and observed that cer-tain inferences by the I-T au-thorities such as provision ofbenefits to certain persons orreceipt of anonymous dona-tions were made without fullyappreciating the facts.

Ramdev trust wins I-T waron tax-exempt tag for yoga

WHAT THE TAX TRIBUNAL SAIDPropagating yoga a

charitable purpose–yoga covers giving medical relief and imparting edu, hence Trust gets I-T exemption

Corpus donations made for specifi c purpose are capital receipts which can’t be taxed

Bulk of donations were small denominations from

yoga camp attendees

Donations also received in cheque, not anonymous

Majority of yoga camp cottages available free to public, even ‘donor reserved’ ones, if unoccupied

ENSURING COMPLIANCE➤ NPPA’s new helpline number 1800111255 for reporting problems related to stents

➤ Any complaint of breach of price cap or shortage may be sent via NPPA website through PharmaJan Samadhan

➤ NPPA has written to all state chief secretaries to ensure compliance at hospitals and retailers

➤ Department of pharma has written to health ministry, NPPA and state drug controllers to ensure that there is no shortage of stents and that consumers are not overcharged

➤ Non-compliance on new price caps can invite severe penalty, cancellation of manufacturing or import licence and even blacklisting of companies

Regulator: Search for,seize stashed stents

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