I. ASSESSMENT OF QUANTITY AND LIST OF DRUGS :
TNMSC is entrusted with procurement and distribution of Drugs and Medicines, Surgical and Suture items to the Government Medical Institutions.
TNMSC finalize the Essential Drug List for drugs, surgical and suture items every year by getting the requirements from the Government Medical Institutions situated through out the State of Tamil Nadu and these requirements are placed in the Drug Committee Meeting convened in the month of November every year.
The Drug Committee consists of the following members:
i) Director of Medical Education
ii) Director of Medical and Rural Health Services
iii) Director of Public Health and Preventive Medicine.
iv) Director of Medical and Rural Health Services (ESI).
V) Director of Family Welfare.
vi) Director of Drugs Control.
vii) Chief Physician
viii) Specialists and Surgeons.
The Drug Committee scrutinize the items in the Essential Drugs, Surgical and Suture List purchased in the previous year and analyse the slow moving, non moving and out-dated items and recommend for the deletion of these items. In addition, the committee also suggest to include certain items of Drugs, Surgicals and Sutures suggested by the institutions based on the essentiality.
Final list of Essential Drugs, Surgical and Suture items will be consolidated after the Drug Committee meeting and the specifications of each items will be arrived along with Pharmacopeia standards. The Drug Committee will also decide on the procurement of quantity for the essential drug list items by analyzing the last year purchase and utilization.
II. CALLING UPON TENDERS :
Tenders will be invited by giving advertisement in the leading all India level newspapers, Regional papers and tender bulletins. Subsequently the tender notifications will be issued to all the State Drug Controllers, Pharma Manufacturing Associations and Pharma publications to increase number of participants and competitors.
The tenders will be received up to the stipulated time in TNMSC and the technical bids will be opened in the presence of the Tenderers/Representatives and Tender Evaluation Committee. The technical bids were opened and scrutinized with the help of the check list by a team of officials drawn from the Director of Drug Control with the Pharmacist from the warehouses.
Evaluations will be done in the presence of the Tenderers/Representatives and those who are not submitting the required documents will be intimated through a letter at the end of the technical bid opening.
After preliminary evaluation the tender documents will be once again scrutinized in the Head office for the specifications etc. In case of any discrepancy noticed during the subsequent scrutiny letters will be issued to the tenderers to submit the clarifications/additional documents.
The manufacturing premises of the tenderers who are participating first time in the TNMSC tender and those who were empanelled previously in TNMSC are compulsorily inspected for the compliance of Good Manufacturing Practices (GMP) and for their production capacity.
Inspection team will be constituted with the officials from Drug Control and end user departments such as Director of Medical Education and Director of Medical and Rural Health Services.
The teams will be sent for inspection to the manufacturing premises with a check list for verification of the GMP compliances and capacity of the tenderer. On the recommendations of the Inspection team the tenderer will be considered for the price bid opening.
Those tenderers who were short listed on technical bids evaluation and on the inspection of the manufacturing premises will be called for price bid opening. The tenderers will be requested to come along with copies of the price quoted for the items and this shall be circulated among the competitors during the price bid opening.
Tenderers are also requested to submit the soft copy of the price along with the price bid of the tender. After opening of the price bid the soft copies will be fed into the Database and the print outs were taken and verified with the documents submitted.
The provisional L1 rates for all the eligible items will be arrived at on the same day, of the price bid opening and Provisional L1 rates will be published in the Website and in the Notice board of TNMSC.
The L1 tenderers will be called for price negotiations as per the Tamil Nadu Transparency in Tenders Act. After finalization of the L1 rates, the L1 rates and the list of tenderers will be placed in the Tender Committee of the Board for verification and recommendation to the Board for approval.
After Board's approval, letters will be issued to the L1 tenderers for execution of agreements and deposit of Security amount. Subsequently, letters also issued to the tenderers who are participated in the tender and request them to send their willingness for matching the L1 rate. The tenderers are also requested to indicate the matched items in the schedule of the agreement.
The matched suppliers will be kept as reserve, in case of any additional requirement and in case of exigency, orders will be issued to the matched tenderers.
If any drugs which are not approved by the Tender Committee and the Board for various reasons re-tenders will be invited for those items and the same will be placed once again in the Tender Committee and the Board for approval as per the value of the item.
III. PROCUREMENT OF DRUGS:
The essential drugs and surgicals are classified as fast moving and slow moving items. This decision has been taken to have more concentration on the fast moving items. Purchase orders will be placed every month for Essential Drug Items and Surgical Items and once in two months for the Suture Items.
TNMSC policy is to have 4 months physical stocks in its 32 District Drug Warehouses and 2 months stocks in pipeline for all the Essential Drug, Surgical and Suture Items. The Purchase order quantity for each drug items will be arrived at, by taking maximum of "average of previous three-years (essential drug) / five-years (surgical and suture) consumptions" and "immediate previous 365 days consumptions", stock available in warehouses, pipeline (from supplier) and inter-warehouse transfer-in stocks.
The "further order quantity" generation are software (DDMS) based and are verified by the Assistant Manager (Purchase) and Manager (Purchase) and put up for approval of the Managing Director through the General Manager along with changes if any on the software generated "further order quantity". After the approval of the Managing Director the purchase orders will be placed and sent to the Suppliers through e-mail, hard copy by courier, servered on hands of supplier / liason officer and made available to download from the suppliers' web-portal. The stocks in the warehouses and their utilizations are closely watched on day-to-day basis by the Assistant Manager (Purchase) and Manager (Purchase).
After receipt of Purchase Orders the suppliers are requested to update the confirmation of receipt of the Purchase order within 3 days from the date of placing the order and to indicate the schedule of supply within 7 days from the date of placing the order in the suppliers' web-portal so as to have a better plan of action on the movement of drugs.
As per the tender conditions the supplier has to supply the ordered quantity within the stipulated time intervals from the date of the purchase order and to complete the supply. If any defaulted on the supply, subsequent orders will be placed with the matched supplier or with the next tenderer at higher rate. The difference of cost will be deducted from the L1 supplier / L1-Matched supplier. These conditions are incorporated to ensure timely supply of the drug and there by TNMSC also cater the needs of the institutions in time and after assessing the quantity of the drugs.
In case of any drug for which the consumption has been reduced in a particular area and if the drug is not required by them, the drugs will be transferred to the required warehouse and also letters will be sent to the concerned institutions and hospitals and ask them to utilize the drug. By this methodology, the expiry of the drugs in the warehouses is avoided.
The same way in the case of any excess drawal of the drugs from the warehouses are also monitored, in case of any epidemic situation, the requirements will be met out immediately by making inter-warehouse transfers.
Once, in a fortnight, the short expiry drugs lying in the warehouses within 6 months are taken and are analysed for their movements. Letters will be sent to end users such as Superintendents, Joint Director of Health Services, Deputy Director of Health Services etc. to convene a Drug Committee Meeting to utilize the drugs in their Hospitals. If any other Hospital in the State require the short expiry drug, those drugs are transferred to the needed warehouses and try to utilize them before expiry. If it is not possible to utilize the drug within the period, a letter will be sent to the suppliers and request them to replace the quantity with the fresh batch of the longer shelf life.
IV. QUALITY PARAMETERS :
As soon as the drugs are received in warehouses of TNMSC from the suppliers, random samples from each batch are send on the same day to TNMSC Quality Control department.
The samples are received in the Quality Control department from all warehouses, common batch of each item are eliminated, the tablets and capsules are removed from the strips and blisters, labels of vials, ampules and bottles are removed and coded with the secret code (Sample Code) and automatically empanelled laboratory will be allotted (randomly with equal weightage) to each sample by software (DDMS). Accordingly the decoded samples will be sent to the respective laboratories for analysis.
The Empanelled Laboratories are requested to analyse the drugs as per the Pharmacopeial specifications such as.
I. Tablets & Capsules:
i) Identification
ii) Disintegration test
iii)Dissolutiontest
iv)Uniformity of the weight
v)ASSAY, etc.
II. Injectables:
i)Identification
ii)pH sterility
iii)Pyrogeon Test.
iv) BET Test and other related substance, etc.
As soon as the "Passed" test results are received from the Empanelled laboratories, the same are updated in the database and quarantine stocks are ready for distribution to Health Facilities.
Any sample sent to the Empanelled laboratories fails in quality, the results will be confirmed with the other Empanelled laboratories / Government Analyst before taking final decision.
If the drug fails in ASSAY or any other parameters, immediately letters will be issued to the warehouses to freeze the stock and ask them to remove from the main stock and kept separately until it is cleared by the Quality Control department. If the Empanelled Laboratories / Government Analyst confirms the failure of the drug supplied by the supplier, the stocks will be returned to the supplier. After 30 days of the letter for return of stocks, if the stocks are not taken by the Supplier and lying in the warehouses, penalty of 2% per week will be levied on the value of stocks in the warehouse till it is destroyed by TNMSC (90 days).
In case of any failure reported by the Government Analyst on the samples drawn by the Drug Inspectors from the Storage points (Health Facilities) immediately a letter will be communicated to the Warehouse in-charges to stop the issue of the product and also request them to retrieve the drug supplied to the Health Facilities.
The Warehouse in-charge will in turn issue letters to each and every Institution where the batch has been supplied for retrieval of the drugs and request hospitals to collect the stocks from the wards and sub-stores and inform the Warehouse in-charge about the quantity available to send back the stocks within two days from the date of receipt of the letter.
The value of the quantity returned to the supplier will be deducted from their any payables and depends on the nature of failures, the Product / Company will be blacklisted after following due procedures.
The Director of Drugs Control is also requested by TNMSC that in case of any Not-of-Standard-Quality (NSQ) report of any drug, on the sample drawn from the Hospital / Institution by the Drug Inspectors, additional samples may be drawn from the same drug (different batches) or other drugs supplied by the same company from different locations in the State, to verify the quality of the drugs during storage.
TNMSC also drawing samples from the batches of drugs lying in the Warehouses, more than 6 months and the same were analysed to counter check the stability of the drugs during storage period.
V. VACCINES & SERUMS :
The supply of vaccines and serums are allowed to be distributed to the hospitals as per the clearance of CDL, Kausuli. In addition to this, samples of the Vaccines were drawn from the warehouses randomly and sent to the laboratories for analysis.
In case of any adverse reactions reported in the Hospitals during administration of any Vaccines, Serums or any Injectables, the Warehouse in-charges are requested to act immediately and to inform the same to the Quality Control department and freeze the drug and retrieve all the stocks from the Hospitals.
TNMSC also taken steps to verify the cumulative ASSAY value of each drug so as to keep watch on the supplier that they are keeping the strength of the drug on the upper limits.
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