Methodology adopted for Quality Control:

Each and every batch of drugs/medicines supplied by the suppliers shall be subjected to quality test by the laboratories empanelled through open tender process.

Three random samples are drawn from each batch of supply from the warehouses and after eliminating the common batch, samples are taken in random, decoded and sent to the empanelled laboratories for testing the quality of drugs.

If any batch of the particular product received after 5 days in any another warehouse of TNMSC then the sample is sent for analysis for once again. In this case the sample is tested by another laboratory.

In order to ensure the quality of the drugs during the storage period also, TNMSC is drawing and analyzing the drug samples which are lying in the warehouse for more than 6 months to countercheck the stability of the drugs during storage period.

As soon as the reports are received from the Empanelled laboratories, the results are up-dated to the warehouses through E-mail.

The Vaccines and Sera of all the batches have to be analyzed even though they are tested in the Central Drug Laboratory, Kasauli.

The samples are received in the Head office from all the 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 number and sent to 3 different Empanelled Laboratories for analysis.

If such sample passes quality test in all respects, TNMSC instructs its Warehouses to issue such items of drugs to various Government hospitals/Institutions.

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 confirm 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 (hospitals) 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 hospitals.

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 over phone and 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 bills and depends on the nature of failures of the product, 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 report of any drug, on the sample drawn from the Hospital / Institution by the Drug Inspectors, additional samples of the same drug (different Batch Nos.) may be drawn (or) other drugs supplied by the same company from different locations in the State, to verify the quality of the drugs during storage.

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 Head Office over phone 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.

Three samples of the same batch are drawn by the warehouse in-charges and send to the Quality Control department, Head office for analysis. Whenever the samples are drawn by the warehouse in-charges the sample has to be drawn from the bottom layer of the boxes.

The total number of boxes received for each batch to be fed into the Computer and the number to be randomly selected by using the Computer and samples to be drawn from that particular number box.

The samples to be drawn from 1/3rd of the boxes, supplied in a particular batch by selecting the numbers randomly through the Computer and the samples to be sent to Head office for analysis.

If any drug is lying in the Warehouse for more than 6 months, the samples to be drawn from that batch as per the instructions of the quality control department of Head office and the samples are to be sent for re-analysis to Head office.

If any batch of the particular product received after 5 days in any another warehouse of TNMSC then the sample has to be sent for analysis once again to another laboratory. The programme is changed in the system accordingly.

The Inspection Officer going for inspection of the warehouse have to randomly select the drug and take samples and the same to be handed over to the Manager (Quality Control), Head office for analysis and outcome of the report has to be reported to the Managing Director immediately.

1. (a) On empanelment and entrustment of the job, the Analytical Laboratory should furnish the test reports within.
        I. 8 days of receipt of the sample in case of Tablets, Capsules, Pessaries, Ointments,Powder and Liquid Oral Preparations.

        II. 21 days of receipt of the sample in the case of I.V. Fluids and Injections.

        III. Within 24hrs of the receipt of the samples, the information in appropriate format should be uploaded to the TNMSC website in addition to confirmation by fax/mail.

        IV. For any delay more than stipulated in 21 a (I) & a (II) as the case may be, 1% of the testing charges per week and the part there of would be deducted as penalty. If consecutively for 4 times or more than 8 times in a year or a delay of more than 10 days occurs over the time period stipulated in 21 a(I)/a(II) then the penalty for subsequent delays would be 2% of testing charges per week and part there of.

b) All the tests mentioned in IP/BP/USP/Drugs & Cosmetics Act. Etc., (as the case may be) should be carried out for each and every sample. The results obtained in the test should be mentioned in figure (wherever possible).

c) “COMPLIES” or “PASSES” in the result column of the report is treated as incomplete report, if the result has some value.

d) Every test report must have remarks (i.e.) Standard Quality or Not of Standard Quality.

e) Reports should be in A4 size (8.27” X 11.69”) paper of good quality.

f) Reports should have Sl.No. Description of tests, Specifications & Results obtained.

g) Reports should be attached along with Spectra/Chromatography data sheets if applicable.

h) Report should be uploaded on the website of TNMSC and simultaneously be E-Mailed to head office, TNMSC apart from sending it by fax/mail.

2. All test reports should be submitted to the TNMSC in triplicate. In case of failure of a sample, the result should be communicated immediately to the Managing Director through phone / Fax / E-mail and the report should be sent with protocol.

3. If in any circumstances (like break down of instrument, non availability of reference standard etc.) the Analytical Laboratory is unable to undertake analysis for a sample, the same should be reported within 24 hours of receipt of such a sample by FAX or E-mail and the sample should be returned to the Manager (Quality Control), Tamil Nadu Medical Services Corporation Limited, Chennai.

4. If any sample is received in a damaged condition by the laboratory, the sample should not be analysed and the information should be sent immediately to the Manager (Quality Control), Tamil Nadu Medical Services Corporation Limited, Chennai by FAX or E-mail.

5. The Managing Director, Tamil Nadu Medical Services Corporation Limited or his authorised representative(s) has / have the right to inspect the laboratories of the tenderers who have submitted tenders, before taking any decision regarding empanelment. Similarly, the Managing Director, Tamil Nadu Medical Services Corporation Limited or his authorised representatives may also inspect any laboratory empanelled, at any point of time during the continuance of the tender and terminate / cancel its empanelment or any orders issued to the laboratory or not to entrust any further testing job to the laboratory based on facts brought out during such inspections.

6. No advance payment towards any analysis will be made to the empanelled tenderer.

7. No payment will be made for the incomplete analysis or incomplete report. Ref: Clause 22(b) to 22 (f).

8. Payments towards the analysis of Drugs, Surgicals and Sutures will be made along with Tax at the prevailing rate as applicable at the time of payment strictly as per rules of the Tamil Nadu Medical Services Corporation Limited, Chennai.

9. If the successful tenderer fails to execute the agreement and payment of security deposit within the time specified or withdraws the tender after intimation of the acceptance of the tender has been sent to or owing to any other reasons, he is unable to undertake the contract, the empanelment will be cancelled and the Earnest Money Deposit deposited by the tenderer shall stand forfeited to the Tamil Nadu Medical Services Corporation Limited. Such tenderer(s) will also be liable for all damages sustained by the Tamil Nadu Medical Services Corporation Limited by reasons of breach of tender conditions. Such damages shall be assessed by the Managing Director, Tamil Nadu Medical Services Corporation Limited whose decision shall be final.

10. Non performance of any tender or empanelment conditions will disqualify a laboratory to participate in the tender for the next five years.

*a) To assess the correctness of the test results being given by the Empanelled laboratories, at random, samples would also be sent simultaneously to the Government Analyst for testing and if any variation is found the result would be informed to empanelled laboratories. If there is any variation in the analytical reports furnished by the empanelled laboratories (either pass or fail) with the Government Lab for 3 times in assay test and 4 times for other than any, in a year, the empanelled laboratory will be blacklisted for a period of 5 years after following the due process.

11. If it is revealed that the analytical Laboratory is involved in any form of fraud and collusion with the suppliers of Tamil Nadu Medical Services Corporation Limited, the Analytical Laboratory will be black listed for a period of 5 years. The tenderers shall also be liable for action under criminal law and the matter will be notified to the concerned Director of Drugs Control for penal action against them.

12. The Managing Director, Tamil Nadu Medical Services Corporation Limited will be at liberty to terminate without assigning any reasons, the empanelment of any laboratory either wholly or in part at one month’s notice. The tenderer will not be entitled for any compensation whatsoever in respect of such termination.

13. In all matters pertaining to the tender, the decision of the Managing Director, Tamil Nadu Medical Services Corporation Limited shall be final and binding.

14. In the event of any dispute arising out of the tender such dispute would be subject to the jurisdiction of the civil courts within the city of Chennai.

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