A Project of
Indian Pharmaceutical Association
In collaboration with
W.H.O. India Country Office
Drugs Controller General of India

PROJECT TITLE                                                                                                             
To prepare an Accreditation Manual of Pharmacies in India

PROJECT PERIOD                                                                                                           
Twelve months

AIM OF THE PROJECT                                                                                                .
1. To provide guidelines for the desirable upgradation of existing systems in the pharmacies, to survive in an environment of competitive challenges.


Under this project, the following material was prepared:
1) Accreditation Scoring Worksheet: To be used by Assessors in the discharge of responsibilities i.e. in carrying out the assessment exercise for accreditation. The worksheet also helps pharmacies in self-assessment so that they know at what stage they are, where they are lacking and what aspects need to be introduced or improved upon. 
The Worksheet consists of:

a. Standard: This is a broad classification head of aspects related to the pharmacy/ medical store. There are 12 standards included in the Worksheet.
b. Finer Standard: This is a sub topic of the standard. Under each standard we have included one or more finer standards.
c. Criterion: These are sub components of the finer standard. For each finer standard there are one or more criterions. These are the main points to be addressed.
d. Guidelines for Ratings (for each criterion): These are a measure or indicators of compliance to the respective criteria and indirectly the finer standard and standard. For each criterion, there are 4 different performance/ achievement guidelines, which the pharmacy have attained and based on this, the pharmacy are given points i.e. 3 or 2 or 1 or 0. Based on the total score, the pharmacy is awarded final gradings. For the purpose of this pilot exercise, the final gradings were Grade A (Above 75%), Grade B (50 – 75%), Grade C (25 – 50%) and Grade D (Below 25%).

2) Accreditation Manual: To assist and guide pharmacists to implement the various criteria, in order to fulfill the requirements of GPP in order to get accreditation scores. The Accreditation Manual describes each criterion under every standard. It gives scope to think of all possible aspects while implementing the set criteria. It also answers the most probable queries or doubts that pharmacy personnel might have. For any additional information, the reader is directed through the Accreditation Manual to the Good Pharmacy Practice Manual, Annexures (at the end of the Manual) and supporting material (reference books, PILs etc.)

Pilot Assessment: 
The Worksheet and Manual were used for pilot assessment of 45 pharmacies (26 from Mumbai and 19 from Goa) out of a total of 70 pharmacies (45 from Mumbai and 25 from Goa) enrolled under the project. This enrolment of pharmacies was on purely voluntary and there were no criteria/ conditions fixed for enrolment. (24 pharmacies expressed inability to participate in the assessment citing various reasons e.g. lack of time).

The enrolled participants were provided with copies of the following material as back-up for taking up the task of upgrading their pharmacies:

a. 10 steps to accreditation: A one page document laying down 10 steps to achieving accreditation to give an idea of how to proceed after receiving the documents. However, pharmacies still have the option of devising their own steps to go about.
b. Accreditation Worksheet
c. Accreditation Manual with supporting material (sample forms and documents etc.)
d. PILS (Patient Information Leaflets) on various ailments (for distribution to patients).

The pharmacies were given a period of 3 months to study the documents and implement criteria. The pharmacies were provided constant support and guidance over the phone, email and personal visits. The pharmacies were then assessed by assessors appointed under the project. They were trained and accordingly the pharmacies were assessed using the Accreditation Worksheet.

Post-assessment analysis:

Total number of pharmacies Enrolled, assessed in the Project, and the grades achieved by them:

Number of pharmacies enrolled45 pharmacies25 pharmacies
Number of pharmacies assessed26 pharmacies19 pharmacies
Grades scored by pharmacies
Grade A (Above 75%)NIL2 pharmacies
Grade B (50 – 75%)13 pharmacies9 pharmacies
Grade C (25 – 50%)12 pharmacies8 pharmacies
Grade D (Below 25%)1 pharmacyNIL

Results: Based on the pilot assessment of pharmacies, IPA has prepared a document suggesting the initiation of the Accreditation system for pharmacies in India and methodology for the same, and is in the process of working out a strategy for implementation of the suggested system.

Accreditation of pharmacies is a system under which standards are laid down based on Good Pharmacy Practice. With the help of these systems, pharmacies can self-assess and appraise the existing systems, compare with the GPP guidelines, determine variances and work towards them. This system will in turn ensure that pharmacies work towards professionalism and render better health care to the community.

Implementing the Accreditation system for pharmacies in India could encourage the maintenance of a standard of excellence and stimulate the process of continual improvement in community pharmacy practice in the country.