CDMU West Bengal Standard Operating Procedures for Quality Assurance  (2003-2004 version)


Quality of drugs is a matter of global concern. This issue is even more important in a developing country like India where the problem of spurious and substandard drugs is rampant. CDMU and its member organizations are justifiably anxious about the quality of the products being procured, stored and distributed by CDMU. At present quotations are invited only from pharmaceutical manufacturers located in the state of West Bengal and manufacturers located outside West Bengal but with distribution outlet in the state. The following Standard Operating Procedures (SOPs) are in vogue for quality assurance by CDMU.
1. Pre-qualification of suppliers

Potential suppliers must be in the field of pharmaceutical manufacturing or distribution for a minimum period of 2 years before they can quote for CDMU.

While submitting quotations, tenderers must furnish CDMU with copies of:

CDMU reserves the right to reject any or all tenders from a particular party in the absence of the above supporting documents.

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2. Tender selection process

The CDMU Pharmaceutical Committee comprises eminent doctors, pharmacists and in-house experts who screen all tenders submitted during the annual closed-door 2-day tender selection meeting.

In addition to price, the Committee considers the supplier's accessibility, market reputation, past performance with CDMU and the nature of the product before making final selection. It is usual practice to select 3 to 4 generic suppliers for each item, so that in the event of one failing to supply, another can be approached.

The Committee also ensures that:
  • Compositions of products quoted conform to specifications in the CDMU catalogue e.g. liquid iron preparations must contain ferrous fumarate rather than ferric ammonium citrate, theophylline controlled release preparations must contain theophylline only and not theophylline plus etofylline.
  • The supplier is in a position to ensure that drugs included in IP, BP, USP or International Pharmacopoeia conform to their respective pharmacopoeial specifications and quality norms.
  • Decides on which samples are to be asked for basic in-house testing before making a final selection.

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3. In-house and external testing

Once the Pharmaceutical Committee has made its recommendations during the tender selection process, samples are asked for, in reasonable quantity, from the concerned manufacturers and distributors. These samples are subjected to certain basic in-house testing e.g.
  • Assessment of organoleptic properties of antacid tablets and suspensions.
  • Assessment of disintegration time of dispersible tablets.
  • Inspection of small volume parenterals.
  • Assessment of the quality and performance of non-drug items, including stethoscopes, sphygmomanometers (BP instrument), IV infusion sets, blood transfusion sets, syringes, adhesive plasters, dressing materials and gloves.
In addition, samples may be sent for more rigorous testing to government approved drug testing laboratories.

The same procedure, that is testing in approved laboratories, is adopted for periodic random checking of fast moving items or items against which definite quality complaints have been received.

The CDMU Chief Manager is empowered by the Pharmaceutical Committee to order recall and replacement of items failing quality testing in the event that such items have already been supplied from the CDMU stores.

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4. Inspection of supplies

The following checks are done on receipt of goods at the CDMU warehouses in Kolkata and Siliguri:
  • Each delivery, supported by proper challan, must comply with the requirements of the purchase order in all respects. 
  • Each delivery must be accompanied by quality control test certificate for each batch from the manufacturers. In the absence such certification, the supplier may be asked to provide batch-wise samples for testing, the cost of which may be recovered from the supplier.
  • Each consignment of supplies must be accompanied by a duly filled and signed 'Supply Norms Compliance Form' to be provided by CDMU along with the order.
  • All supplies must bear labels on the packaging clearly indicating the generic name (international non-proprietary name) of the active ingredients and the exact composition of the products. Supplies without such labeling are liable to be summarily rejected.
  • The packaging would be physically checked to ensure that there are no leakages, breakages, obvious contamination of parenteral products or obvious deterioration of other dosage forms. In the event of obvious quality problems, the consignment again stands to be summarily rejected.
  • No marks other than 'INSTITUTIONAL SUPPLY' or 'CDMU SUPPLY' will be allowed on the boxes, cartons, or strips. Any delivery with the marking 'HOSPITAL SUPPLY' or 'NOT FOR SALE' may be summarily rejected. This applies not only to the outer cartons, but also to the individual boxes, strips, vials, etc.

Shelf-life of all drugs delivered to CDMU must not expire before 12 to 24 months from the date of supply, or longer, as applicable. CDMU reserves the right not to accept any consignment with an unreasonably short expiry period.

Suppliers' bills are not cleared for payment till the materials have been received, accounted for, and found to be of satisfactory quality.

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5. Storage and distribution

CDMU maintains its stores at its Head Office in Kolkata and at Siliguri. The Kolkata store is partially air-conditioned. Both stores have backup power generation system.

Storage norms, as recommended by the Pharmaceutical Committee, are followed. 

Prior to dispatch of a consignment to a Member Organization, the following steps are followed:
  • Individual cartons and packages to be dispatched are selected on the basis of the FEFO (First expiry first out) principle.
  • The packaging is rechecked to ensure that labeling requirements have been met and there are no obvious quality problems.
  • Final repacking is done after verifying with the order and special requirements of the member organization, if any.
Distribution, as far as practicable, is made by CDMU's own transport.

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6. Complaint redress mechanism

Despite CDMU's best efforts, complaints regarding quality are periodically received from member organizations using CDMU supplied products. The following mechanism is in operation at the current juncture to address such complaints.
  • A complaint report is filed and brought to the attention of the CDMU Chief Manager.
  • Depending on the gravity of the situation, the Pharmaceutical Committee is informed.
  • Samples may be dispatched for testing at external approved laboratories as mentioned above.
  • If relevant, the manufacturer / distributor of the product is informed.
  • The member organization is intimated about the results of the deliberations and, if feasible, the defective stock is replaced.
The following points are to be noted in this regard:
  • For all accepted tenders, the tenderers furnish a security deposit @ 5% of the estimated contract value. This security deposit carries no interest and is refunded to the tenderer after two years from the date of supply of that particular consignment to CDMU, if supplier performance is satisfactory.
  • CDMU will withhold payments against bills of a supplier found to have delivered sub-standard drugs.
  • Further, the security deposit is liable to forfeiture if the tenderer fails to deliver contracted drugs within the timeframe specified in CDMU's purchase order, supplies sub-standard drugs or indulges in any illegal or immoral activities detrimental to CDMU's reputation.
A lot remains to be done in the field of quality assurance. It is a well-known fact that ensuring the quality of medicines and medical supplies is a complex and technically difficult task. The SOPs outlined above have evolved over the years through collective experience. Despite this lacunae still remain. CDMU's own stores, for instance, are not ideal owing to lack of adequate storage space. Another major limitation is the lack of comprehensive in-house testing facilities. Operating within these constraints, we solicit earnest cooperation of all our suppliers, staff and member organizations to help us to fine tune the SOPs and maintain quality of all our products. This is in the greater interest of the ailing and the needy who consume the medicines distributed by CDMU.

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