FREE ESSENTIAL DRUGS POLICY IMPLEMENTATION STATUS STATE OF ODISHA

Free Drug Policy for EDL notified in the State (Y/N) Facility wise EDL notified (Y/N). Please provide list Standard Treatment Guidelines (Y/N) Prescription Procurement Agency (State Corporation Audit Mechanism /Society/Directorate/Others -name it) (Y/N) Software application for the procurement & distribution of drugs in the state Which agency Brief Note on Free Drug System with has developed details about Procurement Agency, rate fixation, procurement / is developing (Centralized/Decentralized), tender software eligibility conditions such as GMP application certification, market standing, annual CDAC / NIC / turnover etc, logistic system, Others name warehousing facility, quality assurance it system etc. Luminous Info Detailed information given at ways, (Annexure-VI) Bhubaneswar.

Yes (Details at Annexure I)

There are two Yes notified EDLs : STG for 1) EDL (General): Mother & 310 items & 10 Child has Combi- Packs been prepared 2) EDL (Children): (Details 165 Items. (Annexure- II A & at http://n B) rhmorissa. gov.in/JSSK The revision of /pdf/Stand the above EDLs ardTreatm along with entandEss Facility wise EDL entialMedi is under process. cineList.pd (Annexure - II C) f

Yes (Details at Annexure III)

Presently the Procurement Agency is State Drug Management Unit (SDMU), which is a unit under Directorate of Health Services, Govt. of Odisha for procurement of Drugs & Equipment. In the meantime, the Odisha State Medical Corporation is formed and the Managing Director of the Corporation has been appointed. The Corporation will take over soon all procurement activity of Drugs & Equipments of the State. (Details at Annexure IV)

A Webbased application software called Odisha Drugs Inventory Management System (ODMIS) is developed. Inventory management module is operational upto CHC level since April 2013. Procurement & other modules is operational since August 2013 at State level. (Details at Annexure V)

ANNEXURE - VI
1) Procurement Agency : State Drug Management Unit (SDMU) which is a unit under Directorate of Health Services, Govt. of Odisha 2) Rate Fixation of Drugs: Through National Competitive Bidding Process in every financial year. Rate finalized is valid for a period of one year from the date of Govt. approval. 3) Procurement System : a) Centralized: The procurement related to 80% of the state drugs budget is done centrally by the state procurement agency, i.e. State Drug Management Unit (SDMU). b) Decentralized: The procurement related to 20% of the state drugs budget is done at the District level to meet the emergency requirement. 4) Tender eligibility conditions: a) Tenderer shall be either a manufacturer or loan licensee or an importer (having valid import license and product registration certificate issued by the Drugs Controller General of India). b) In case of manufacturer or Loan licensee, it shall have a *valid manufacturing drug license or valid renewal drug license issued by the State Licensing Authority / Central Licensing Approving Authority (wherever applicable). If the validity of drug license expires on the date of bid opening, validity certificate / renewal application acknowledgement certificate in lieu of valid manufacturing license / renewal license from licensing authority will have to be submitted. c) In case of importer, it should have a *valid import license and product registration certificate issued by the Drugs Controller General of India. d) In case of manufacturer, it shall have *valid GMP certificate as per Revised Schedule M of Drugs & Cosmetics Rule 1945 (by & large GMP certificate will not be accepted) / COPP (Certificate of Pharmaceutical Products) certificate issued by the concerned licensing authority. * Valid certificate means the certificate should be valid on the date of bid opening. e) In case of importer, WHO GMP (of Manufacturer) shall be submitted. f) Distributors / Suppliers / Agents / C&F Agents / C&A Agents are not eligible to participate in the tender on behalf of any company. g) Tenderers (manufacturer / importer) shall have a minimum turnover of Rs. 15 Crores or more from pharmaceutical products in each of the year for last three financial years for Category I, II & III Items; Rs.10 Crores or more from pharmaceutical products in each of the year for last three financial years for Category IV & V Items for last 3 (three) financial years; Rs. 35 Lakhs or more from pharmaceutical products in each of the year for last three financial years for Category VI Items for last 3 (three) financial years, i.e. 2009-10, 2010-11 and 2011-12. The proof of turnover is to be furnished in the prescribed format certified by the Chartered accountant & should be supported by annual audited statement.

h) Tenderer / manufacturing unit which has been blacklisted / debarred by the tender inviting authority (Directorate of Health Services, Odisha) cannot participate in the Tender for that item(s) during the period of blacklisting / debarment. i) Tenderer / manufacturing unit which has been blacklisted / debarred by any other state Government or Central Govt. Organisation due to quality failure of the drug(s) supplied cannot participate in the Tender for that item(s) during the period of blacklisting / debarment. j) Tenderer shall have experience in supplying drugs & medical consumables to the Government / Corporate / PSU / Pvt. Hospitals in India as a manufacturer or otherwise during the last three years. The details are to be submitted in the prescribed format (Market Experience). Copies of the Purchase order /contract has to be furnished in support of the details mentioned in the Market experience. 5) Supply Chain & Logistics System : As per the tender terms & condition, the supplier directly delivers the drugs at the central warehouses of all districts. Only 10% buffer stock is delivered at the central warehouse in Bhubaneswar. After receipt of drugs by the district central warehouses, the same is delivered to the respective DHH / CHC warehouses of the concerned district by the district authority depending upon the requirement (indent). Again after receipt of drugs at the CHC warehouses, drugs are delivered to the concerned PHC / Sub centre depending upon the requirement (indent). Fund provision are made in the NRHM PIP for strengthening the required logistic support (transportation, fuel etc.) for both District (from District to Block CHC) & Block CHC (from Block CHC to PHC & SC). 6) Warehousing Facility: a) Medical College & DHH Level: Warehouses equipped with heavy duty racking system. b) SDH Level : 7 Warehouses with racking system has been completed and construction of warehouses in rest 20 SDHs will be completed in 2013-14 c) CHC Level : Warehouses with racking system has been completed in 97 Block CHCs & construction of warehouses in rest 217 CHCs will be completed in 2013-14 7) Quality Assurance System : As per the tender terms and conditions, the supplier delivers the drugs with testing certificate from the NABL accredited laboratories (Pre-supply quality testing) based on which the same is accepted at district central warehouses & distributed. Again, the quality checking is carried out by drawing random samples from the supplied drugs (post-supply quality checking) of each batch and the same is sent to NABL accredited laboratories. Payment is made to the supplier after getting the Standard Quality test report from the laboratory.