3. Indian producers
♣ Panacea Biotech
♣ Samarth Life Sciences
♣ German Remedies
♣ VHB Life Sciences
♣ Chandra Bagat Pharma
4. ♣ No / Limited drug supply from Mid July 2016
Why?
♣ Official reason: Raw material from China unavailable
♣ Possible actual reason:
- The drug came under price control.
- Suppliers unwilling to give raw material at
competitive price.
- The few raw material suppliers in India began exports.
Issue with Penicillamine
5. 1. C D S C O 2. N P PA
Drug regulators in India
6. C D S C O
• Central drugs standards and control organisation
• Is headed by the Drugs controller general of India( DCGI)
• Comes under the ministry of health & family welfare
Functions:
1. Prescribes standards for ensuring the safety, efficacy and
quality of drugs, cosmetics, diagnostics & devices.
2. Regulates the market authorization of new drugs and
clinical trials standards
2. Supervises drug imports and approves licences to
manufacture the above-mentioned products
7. N P P A
• National pharmaceutical pricing authority
• Instituted in 1997
• Comes under ministry of chemicals & petrochemicals
Functions:
1. Fixes/ revises prices of decontrolled bulk drugs and
formulations at judicious intervals
2. Updates price control list by inclusion/exclusion of drugs
3. Maintains data on production, exports and imports and
market share of pharmaceutical firms
4. Enforces/ monitors availability of drugs medicines
5. Answers questions in parliament
8. Drug pricing
• Those not under price control:
Companies can decide the MRP. The NPPA intervenes
only if there is increased sales/annual price is up > 10%
• Those under price control:
Drugs with high market share> 50%. ( scheduled drugs)
Has declined over time: 1979 it was 342 and 74 in 1995.
From 2013, numbers have increased .. it is 347
10. • Called a meeting of all stake holders on sep 30, 2016
• Companies side:
1. They have registration for import of bulk Penicillamine
from China. However that site is not manufacturing
the drug for six months. The alternate source in China
is ready, but not registered in India.
2. There is valid license for import from China, but source
not ready for supply beyond 2018.
DCGI promised to register alternate supply sources
Steps from the DCGI
13. VERY URGENT
Date: 29th
November 2016
The Chairman,
National Pharmaceutical Pricing Authority,
Ministry of Chemicals and Fertilizers,
Govt. of India
Re: Non-availability of life saving drugs for Wilson Disease
Dear Sir,
I write to you out of great concern for people living with a rare disease called Wilson
disease.
I would like to bring to your notice that the drug for treating Wilson disease is D-
Penicillamine, which is a life saving drug for persons with this disease. This drug was
being manufactured / marketed by Panacea Biotech, V.H. Bhagat and Samarth. However,
since June-July 2016, this drug is not available in the market.
On behalf of Children’s Liver Foundation,……………………………………..
………………………
Dr. Aabha Nagral
Managing Trustee, Children’s Liver Foundation
14. Letter to NPPA under RTI
29th November 2016
Central Public Information Officer
National Pharmaceutical Pricing Authority,
New Delhi – 110001
Re: Application of seeking information under the Right to Information Act, 2005
URGENT: Under Section 7 – as it concerns the Life and death of patients with Wilson
disease.Kindly respond within 48 hours.
Part – I
Name of Application: Dr. Aabha Nagral, Children’s Liver Foundation
Gender: Female
Father/ Mother’s Name: DrDevesh Thakur
Address of correspondence: 7, Shehasagr, Prabhanagar, Prabhadevi, Mumbai 400 025
Tel./ Mobile No.: +919820156834
Email: aabhanagral@gmail.com
Part – II
Information sought: Availability of Drugs for Treatment of patients with Wilson Disease
Description of information required:
.
15. Other efforts
♣ ISPGHAN efforts at Ministry of health
♣ Efforts to contact companies for help
♣ Tapping the illegal penicillamine supply
♣ Looking at alternate small Indian companies
♣ 3 brands were checked for quality
16. The real issue with penicillamine :
1♣ India is widely regarded as the pharmacy of the world-
♣ Till recently, many ingredients going into those drugs were
produced within the country.
♣ Plans to rebuild India's bulk drug sector is under threat, since
support for raw material manufacturers promised by the
Indian Govt was slashed from $750 million to just $90 million.
♣ China's burgeoning active pharmaceutical ingredient (API)
industry has been claiming market share from Indian Co.
♣ Chinese bulk drug imports are cheaper than our producers
because they are subsidized by the Chinese govt.
♣ With low profit margins our bulk producers are squeezed out
17. The real issue with penicillamine
♣ Around 80% of all APIs used by India's drug producers now come
from China, says the Indian Drug Manufacturers' Association (IDMA).
♣ After the recent penicillamine fiasco, CDSCO was forced to ask
domestic manufacturers to step in to restore supply, years after they
were driven out of the market by low-cost Chinese competition.
♣ Other drugs could be at risk, too. India's Bulk Drug Manufacturers
Assoc says more than 12 essential drugs are vulnerable.
♣ Recently the PMO wanted wholesale changes to pharmaceutical
policy to support both the bulk/finished drug industries
18. The real issue with penicillamine:
2
♣ The WHO in 1977 has introduced concept of essential medicines.
♣ The Indian list has 348 essential drug molecules. Pencillamine was
added on 9th
May 2016.
♣ Earlier, essential drug price was based on manufacturing costs. Now it
is calculated by taking simple average of all drug brands having a
market share > 1 %. The final MRP would factor in 16 % to the retailer.
♣ This shifts price calculation from cost based to market based method.
♣ Price caps on drugs considered essential tend to erode the margins of
manufacturers, making their production unviable.
19. The Penicillamine saga
♣ Is likely to be repeated with other drugs also
♣ Essential drug pricing mechanism needs re visiting
♣ Bulk drug manufacturing industry needs support
♣ Trientene needs to be looked at.
