CHANGES SUGGESTED BY CSF ACCEPTED FOR INCLUSION IN DRAFT DRUG POLICY OF J&K

           
CHANGES SUGGESTED BY CIVIL SOCIETY FORUM ARE GIVEN IN RED:

            To provide cost-effective and efficient procurement and supply management system for drugs. (ACCEPTED)

Although, there may be about 20,000 medicines/ combinations available in the market, with about 300 drugs recommended by the World Health Organization and 348 drugs in the National List of Essential Medicines, 2011 adopted by the Government of India, it would be possible to tackle almost all disease conditions. (ACCEPTED)

State Drug Committee which would be responsible for initially preparing and subsequently updating every two years the essential drug list for the public sector.  The Committee will comprise Clinicians, Pharmacologists, Microbiologists, qualified Pharmacists and independent experts in the field besides senior functionaries of the Department...(ACCEPTED)

         In some cases the choice may be influenced by other factors such as pharmacokinetic properties or by local considerations such as the availability of facilities for storage. Other local considerations as listed below shall be considered for this purpose:

a.                Effects of local diseases or conditions and food habits on drug effectiveness (e.g., malnutrition, liver diseases etc).

b.                Local differences in sensitivity and resistance of micro-organisms.

c.                 Differences in climate, topography and other environmental factors. (ACCEPTED)

Medicines selected must be available in a form in which adequate quality, including bioavailability and stability can be ensured. (ACCEPTED)

 

    The warehouses/stores shall be managed by appropriate number of skilled and qualified personnel (which will include qualified pharmacists) in line with the principles of good store management.

a.       Drugs shall be stored as per good storage practices and in accordance with FEFO (first-expiring-first-out) and FIFO (first-in-first-out) fashion.

b.       Cold chain storage shall be maintained, wherever required.

c.        Procurement of bulk/loose drugs shall be avoided to prevent contamination and pilferage due to manual handling.

d.       Transport facilities will have to be strengthened for proper and timely distribution to all districts and blocks.

e.        Appropriate disposal of banned, expired and recalled drugs shall be effected in accordance with well-   established norms e.g., WHO guidelines and special care shall be taken for the disposal for antibiotics. (ACCEPTED)

       The said organization needs to be strengthened through a capacity building process by augmenting infrastructure, manpower and financial resources. Adequate communication, transportation, accommodation, and legal assistance facilities shall be provided to the inspectorate staff in all districts. All provision of Drugs and Cosmetics Act relating to AYUSH medicines shall be enforced. Necessary laboratories for testing of Cosmetics shall be established. (ACCEPTED)

      The drug testing laboratories would be accredited with national and, where possible, international accreditation bodies to ensure the reliability of tests as per national/international standards.  Annual testing load and average testing time of the existing drug testing laboratories shall be fixed for greater accountability. (ACCEPTED)

       Private sector laboratories may also be involved to ensure the quality of drugs in the State. However, these would need to be approved, accredited and supervised by the State or central authorities, as the case may be. (ACCEPTED)

     Therefore a statistically designed, scientifically managed, statewide survey shall be conducted collecting samples from every nook and corner of the state and testing them for their quality and authenticity, to measure the extent of spurious drug menace in J&K state. (ACCEPTED)

     Creation of  intelligence cum legal cell to facilitate busting of spurious drug rackets and their prompt prosecution respectively will receive thrust. (ACCEPTED)

     Drug sale licences shall be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments shall be made in the relevant Acts to enforce this provision.  (ACCEPTED)

      Proliferation of drug distribution outlets will not be encouraged.  (ACCEPTED)

      A separate policy for drugs belonging to AYUSH systems of medicine shall be framed. (ACCEPTED)

      In-house Quality Control cells will be established in every major hospital as part of their comprehensive Quality Assurance system. Services of qualified pharmacy graduates in all division, district and sub-district level hospitals shall be made available. (ACCEPTED)

       Clinical Pharmacy and Pharmaceutical Care Services shall be established in all hospitals for maximizing the clinical outcomes of drug therapy and bridge the communication gap between doctors and patients. (ACCEPTED)

      Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be regulated with a greater vigil by the inspectorate working under Drug and Food Control Organization, J&K. Record-keeping of such drugs shall be made indispensable and the same shall be checked regularly by the inspectorate. Special checking squads under the leadership of deputy drugs controllers will be framed and authorized to undertake periodic necessary inspections in this regard along the length and breadth of the state. License to sell, stock and distribute drugs pertaining to Schedule X shall be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities. (ACCEPTED)

      J&K Pharmacy Act 2011 (samvat) will be updated and strengthened and the J&K Pharmacy Council shall endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy. This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. (ACCEPTED)

       In keeping with the constant needs and constraints, special provisions shall be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development. (ACCEPTED)