[Public Health] NPPA, Drug Price control, Sravan Implant, Cigarette packing rules update

1. Prologue
2. NPPA: National Pharmaceutical Pricing Authority
   1. Drug pricing controversy
   2. Scene 1: NPPA price controls begins (Dec 2013)
   3. Scene 2: NPPA tries to go beyond its mandate
   4. Scene 3: NPPA humiliated*
   5. Behind the curtains
3. Sravan implant
4. Cigar-Labelling

Prologue

Current affairs related to public health, during September Week1 to October Week3.

• Part1: Mother, Children, Hunger, Nutrition related.
• Part2: Policy / Mission: Mental health, Ayush
• Part3: “Selling” related: NPPA, Sravan implant, Cigar labelling. You’re here.

NPPA: National Pharmaceutical Pricing Authority

Q.Write a short note on National Pharmaceutical Pricing Authority(NPPA). 100 words.

• NPPA is an Attached office under Department of Chemical and petrochemical, under Ministry of chemicals, fertilisers and pharmaceuticals. (and not under health Department)
• Motto: Affordable medicine for all.

Functions

• Under Essential commodities Act (ECA), Government had issued Drug price control order.
• NPPA enforce this Drug price control order.
• It monitors drugs production, availability, import-export database
• Tries to prevent shortage of drugs.
• Advices Government on drug policy.
• Doesn’t deal with drug licensing or clinical trials. Those functions are under Drugs control general of India (DGCI) under health ministry.

Drug pricing controversy

Gist of NPPA Drug price control controversy

Relevance: (GSM3) issues relating to intellectual property rights.

Scene 1: NPPA price controls begins (Dec 2013)

• Government passes drug price control order. (DPCO)
• Earlier a Committee had prepared the National list of essential medicines (NLEM) with total 348 drugs. NPPA begins controlling their price.

Drug pricing formula

• Take MRP of all companies having >1% market share.
• Take average of those MRPs.
• No company can sell drug at price above that ceiling.

But Mind it: This formula applies only to those 348 drugs.

Scene 2: NPPA tries to go beyond its mandate

• 2014, May month: NPPA issued new price control order on ~108 non-scheduled medicines, dealing with heart, diabetes, TB and cancer.

• Matter goes to Delhi Highcourt. Taarikh pe Taarikh…Fast forward to:

Scene 3: NPPA humiliated*

*Just like Indian cricket team in every second or third match.

• 2014, September: Government revokes that paragraph 19 from Drug price control order.
• Therefore, NPPA automatically lost power to control prices of those 108 drugs which are not in the NLEM-list.  (National list of essential medicine).

But NPPA is not sitting idle.

• NPPA began updating the NLEM list on Government advice. (in other words, they’ll try to add those 108 drugs within NLEM, and thus get automatic power to control their prices as well.)
• Last time, NPPA updated the list 8 years ago, but it came into effect 4 years ago. So it remains to be seen how long it takes this time.
• Obviously, pharma companies don’t like this. Hence more court cases ahead, topic to remain in news forever to harass UPSC aspirants and B.Pharma grads. in job and MBA interviews.

Behind the curtains

• Scene1: USA has put India under “priority watch list” in the “Special 301 report” because of the “unfavorable” IPR regime. Pharma MNCs always criticize India for unfavorable patent and pricing rules.
• Scene2: Government removed price control (to benefit those pharma MNCs) just before Modi visited USA in September 2014.
• Scene3: USA began “out of turn review” of India under special 301 report in October 2014.

If you connect the dots: Modi revoked drug control to get India out of the watchlist in special 301 report. Consequences?

• Drugs will get expensive
• Pharma MNCs may increase ‘investment’ and thereby jobs in India.

Although it doesn’t mean Pharma MNCs only operate to rob and loot everyone on 24/7 basis. In 2014, September. Gilead (US co.) signed agreement with 7 Indian pharma companies, permitting them mfg. and sell Hepatitis C drug (Sofosbuvir/Sovaldi) at an affordable price in India.

Sravan implant

Q. Write a note on Sravan Implant. 100 words

Sravan cochlear implant

• 10 lakh Indians suffering from hearing loss. 10,000 newborn with same problem.
• Cochlear implant / bionic ear: It gives hearing perception to such patients.
• Problem? Imported device costs nearly 8 lakh rupees.
• Solution? DRDO, Armed forces medical college and other Indian labs have produced a cheap device named “Sravan Implant”.
• It has two units (1) Cochlear implant (2) speech processor.
• Costing ~1-1.5 lakh rupees = cheapest in the world but without compromising quality.
• It is not for sale yet. They’ve filed clinical trial application to DGCI (Drug controller general of India).

Cigar-Labelling

• India had signed and ratified WHO Framework Convention on Tobacco Control
• But so far has not complied with the minimum rules.

• Recent report even says India sucks the most among SAARC nations in package-warning.
• Consequences: social cost of tobacco use= Rs.~1.5 lakh crores in cancer and death (2011)
• Solution: Finally Government woke up and amended the Tobacco products packaging rules. (in Oct 2014)

W.E.F. from 1st April 2015:

• Every cigarette packet will carry the statutory warning on both sides, covering total 80% area.
• with photo of throat cancer (60% space)
• With message in English, Hindi or any Indian language. (25% space)
• Benefit? Customer most likely to notice those gory images and give up smoking sooner or later.

Criticism

1. Most rural men use bidis, they don’t contain such labels.
2. Most urban youth too cheap to buy entire packet. They only buy 1-2 cigarates loose from the vendor. Hence unlikely to see the gory images
3. Ban on smoking in public places, is not strictly enforced.