CDSCO Committee to draft new guidelines for effective recall of substandard drugs

New Delhi: To examine the issues regarding effective recall system of drugs found Not of Standard Quality (NSQ) and to review the recall guidelines for updating the same in the present context, the apex drug regulatory body, Central Drugs Standard Control Organisation's (CDSCO) Drugs Consultative Committee (DCC) is planning to draft new guidelines.

In this regard, the CDSCO Committee constituted a sub-committee that examined the matter considering all the parameters and submitted the following recommendations:

• Strengthening of existing system (short term and immediately achievable goal) - To be done immediately with present infrastructure, IT support system, online system, published guidelines to ensure effective recall of NSQ drug and uniform implementation of the same by all the SLAs, UTs and CDSCO e.g. appointment of nodal officers in each state, UT, CDSCO zones and subzones, constitution of special committee at the central level etc, amendment in Rules, use of currently available electronic media like WhatsApp group etc.


• Further strengthening within the shortest possible time (medium-term goal) - Creation of Drugs Control websites for uploading Not of Standard Quality reports, development of Mobile App based system etc.


• Future plan (long term Goal) - Development of online portal/ web-based services connecting pan India - all stakeholders – Heads of Government testing laboratories at Central and state levels, regulators at all levels - Drugs Inspectors, their Controlling or Licensing Authorities and Nodal Officers in case they are different from LA/CA, supply chain (Stockist/ distributors/ wholesalers/ C and F/ retailers as association and individual entity, all association of manufacturers etc.

After detailed deliberation, CDSCO committee, DCC agreed to the recommendations of the subcommittee for making Rules/guidelines. Further, to protect the public from the potential use of Not of Standard Quality (NSQ) Drugs after its declaration, the committee recommended that CDSCO shall immediately publish such data/reports on its website for which the State and Central Drug Control Authorities shall inform such cases of NSQ to the CDSCO by email at enforcecell.div@cdsco.nic. in immediately after such declaration by the Govt Analysts.

It should also be ensured that the reports of NSQ drugs after the declaration to be informed by the State or Central laboratories immediately to the concerned Drug Control authorities.

Further during the discussion in continuation to this point, it was also recommended to update the status of action taken (up to its logical conclusion as per Drugs and Cosmetics Act and Rules) by the respective authorities on Not of Standard Quality drugs especially those identified under the National Drug Survey programme.

During the deliberation, members raised the concern about the recording of storage condition by Drugs Inspector while drawing the sample for test or analysis. To make it a uniform practice, DCC recommended to include provision for recording storage condition in Form-17 of Drugs and Cosmetics Rules. Further Committee also recommended making the provisions under the Drugs and Cosmetics Rules to mention the storage conditions on the label and that while supplying the drugs the distributors/suppliers shall ensure and record on the supply documents or bills that drugs are supplied as per storage
conditions on the label.

Similarly, receiver/purchaser for further sale/ distribution shall ensure and record on the receiving document that drugs were received in the appropriate conditions as per label. Further, the recall of drugs whenever required shall also be the responsibility of wholesalers/ distributors/ retailers.

For maintenance of proper supply chain storage condition, while medicines are sold and are expected to remain with patients for a certain period of time, it is imperative to counsel the patient about the drug in the prescription for his safety.

Therefore, DCC also recommended that provisions shall be made under the Drugs and Cosmetics Rules that, medicines which are required to be sold on prescription of RMP, shall be dispensed with counselling by the Registered Pharmacist.
Subsequently, members also raised concerns about uniformity in test reports.

DCC felt that detailed examination is required to take further action in this regard. Therefore, DCC constituted a subcommittee under Chairmanship of Shri Hariharan, Director(I/c), CDL, Kolkata to examine and give recommendation in the matter about sampling, testing and test reports.

The sub-committee includes C. Hariharan, Director(I/c), CDL, Kolkata (Chairman), Dr Raman Mohan Singh, Director, CDTL, Mumbai (Member), Director/Representative of CDTL, Chennai (Member), Dr R. A. Singh, Director, RDTL, Chandigarh (Member), State Drugs Controller, Gujarat (Member), State Drugs Controller, Maharashtra (Member), State Drugs Controller, Andhra Pradesh (Member), Director/Representative of CDL, Kasauli (Member), Dr A. Ramkishan, DDC(I), CDSCO(East Zone) (Convener).

The sub-committee will examine the report and submit their recommendations within three months to the DCC for further consideration.