Geneva 21 Nov 2011

Better Medicines for Children – India

Overview of the project

Dr Gitanjali Batmanabane & Dr Kathy Holloway, WHO South-East Asia Regional Office, New Delhi.

Third Partners Meeting on Better Medicines for Children22nd November, WHO Headquarters, Geneva, Switzerland

(presented by Dr K Weerasuriya, MAR/EMP)

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Overview of BMC-IndiaOverview of BMC-India

How did we get started?

How was it done?

What has been done?ProductsSurveyOther activities

What else will be done?What were the challenges?Where did we get stuck?

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How did we get started?How did we get started?

Meeting of stake-holders in 2-3 Feb, 2010 New Delhi to formulate objectives and plan road map.

EMLs of states analysed with the national EML and WHO EMLc and presented at the meeting.

* Some key points of the review

*None of the states (except Orissa) had medicines for diarrhoea – e.g zinc sulfate

*The ORS was the old WHO formulation

*Many irrational fixed dose combinations

*No child-friendly formulation of medicines for anemia, tuberculosis, epilepsy and other diseases.

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How did we get started?How did we get started?

Selection of statesChhattisgarh & Orissa chosenBelong to EAG (Empowered Action Group) StatesPoor health statistics

National level activity Preparation of EMLc by the Indian Academy of Paediatrics

State level activities (Chhattisgarh & Orissa)Conduct pricing and availability surveysPrepare a state EMLc

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How was it done?How was it done?

In each state, 2 committees were formed, one for the preparation of the EMLc and the other for conducting the pricing and availability survey. In Chhattisgarh, both activities were under the direction of one coordinator whereas in Orissa there were two (one for each activity).

Sub-committee for EML - Chhattisgarh

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How was it done? (the tools)

The pricing and availability surveys were done according to the WHO-Health Action International protocol for measuring medicine prices, availability, affordability and price components.

The essential medicines for children on the lists were selected according to the WHO guidelines for selection of essential medicines and were based on the WHO Model EMLc.

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What has been done? (the products)• The EMLs have been prepared in both states incorporating

formulations of medicines for children.

Can be freely downloaded from the official website of

the Ministry of Health & Family Welfare, Chhattisgarh

State.Hard copies can be obtained from the State Drug Management Unit (SDMU)

or Ministry of Health & Family Welfare, Orissa State, Bhubaneshwar.

Products: The IAP EMLc• The first draft list prepared by the IAP had > 600 drugs.• After review, the number was reduced to 344.• The IAP then prepared a list of 60 medicines

(and released it to the lay press) which lacked essential medicines like ORS.

• This list was reviewed by a panel of national and and international experts.

• Based on those comments, the WHO prepared a draft list which was sent to the IAP for ratification.

• A final draft list with 113 medicines was initially agreed upon, but some members further objected to this.

• After further revision, a list with 134 medicines has been agreed upon which is based on the WHO EMLc template.

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What has been done? (Survey Results)

• The pricing and availability surveys have been completed in both states and reports have been submitted.

• Availability of essential children’s medicines was very poor in the public sector of both states (17%).

• In private sector, availability was 46% in Chhattisgarh and 38.5% in Orissa.

• There were no paediatric antiepileptic formulations available in the public and private sector in both states.

• Simple antibiotics like amoxicillin were not widely available. • There was good availability of ORS but poor availability of

zinc in both states.

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Survey ResultsComparative availability of zinc and ORS

Drug names and strength

ChhattisgarhAvailability (%)

OrissaAvailability(%)

PublicN=75

PrivateN=60

PublicN=83

PrivateN=79

Zinc sulphate 20mg dispersible tablet

29 0 2.4 3.7

ORS - packet to make one litre solution

93 87 91.5 85.4

Both states did not procure any zinc for 2010-2011.The 29% in C.G was due to the Micronutrient Initiative in nine districts The 2.4% in Orissa was due to local purchase in a single facility.

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What else was done?What else was done?

TAPE study done in two sites – i.e. Cuttack and PudhucherryPaediatric pharmacovigilance initiated in these two sitesReview of the paediatric clinical trials registered in the Clinical Trials Registry – IndiaInitiatives to include paediatric clinical pharmcology in the medical curriculum – UG & PGSix abstracts based on work done in India was presented in ICIUM 2011Training of 400 medical officers in Chhattisgarh (ongoing) (will be completed by mid-December 2011)

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What else will be done?What else will be done?

Training of trainers – to impart training to pharmacists on supply chain management in Orissa. (30 trainers)

Training of pharmacists in Orissa (by the trained trainers) on drug supply chain management (will be completed by April 2012) – 360 pharmacists in the first phase.

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What were the challenges?What were the challenges?

Getting permissions – long time taken, delegation of responsibility, signature of govt. officials, ethics committee approval.

Communication issues– contacting PI, lack of communication between the IAP members.

Budget - under or over estimate

Report writing - delay, facilitation, editing

Quality of data, quality of the selection of drugs in EMLc

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Where did we get stuck?Where did we get stuck?

Preparation of EMLs – concept & principles of selection – not understood by many

Professional bodies like IAP – the EML is not seen as a whole

EML is ready (in states) but procurement is blocked

Ethics clearances, financial issues (bank account)

Post survey refractory period – was long – however activities have started after nearly eight months

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Has procurement begun?• In Orissa the small scale industry manufacturers have gone

to court against the government and won a legal battle against the State Drug Management Unit procuring medicines from prequalified suppliers. Hence procurement from the new EML has not begun.

• In Chhattisgarh, procurement has not yet taken place though the Chhattisgarh Medical Services Corporation was established along the lines of the Tamil Nadu Medical Services Corporation. However, due to litigation, recruitment for posts is yet to begin.