In an effort to simplify and rationalize the sampling
process and maintain an omnichannel database of monthly samples, the Central Drugs Standard Control Organisation (CDSCO) published its final versions of regulations for the sampling of cosmetics, drugs, or medical devices by drug inspectors from the Central and State drug administrations.
The main goal of the guideline is to utilize the available
information and identified risks in the selection of the location and sample to
encompass a wide range of cosmetics, drugs, and medical devices that are
circulating in the marketplace from manufacturing facilities wholesale outlets, and retail outlets, as well as the government distribution channels and so
on. in urban, suburban, and rural areas. It’s also important to keep
an NSQ/Spurious drugs centralized monthly list and post it on the CDSCO website
to stop the use of these drugs in the future.
“The guideline will be useful for effective surveillance for
quality & efficacy of drugs & cosmetics available in the market by
adopting uniform drug sampling methodology for drug inspectors under drug
regulatory authorities of state and central,” said the regulator for drugs.
The guidelines state that drug inspectors must create sampling plans on an annual and monthly basis to select samples based on identified risks, choose the sampling sites by certain criteria, and complete the procedure within the timeframe set by the Central Drug
Regulatory Authority.
Drug inspectors, working with the controlling authority will
prepare a sampling program every month and annually, covering
the whole territory or jurisdiction of their control. The sampling plan
should comprise tribal and rural regions, drugs used in areas that are endemic to certain diseases, medications for seasonal illnesses, and so
on. The regulator has noticed that the areas of distribution in the interior or
rural areas are not included and the drug quality at a distance or in the last
user is not assessed.
The annual sampling schedule will be distributed to the head
office of their headquarters to ensure that it is reviewed regularly to avoid
any repetition in sampling of a single brand and include the maximum number
of categories or brands within the planned sampling schedule.
The selection of a drug is contingent upon several
aspects, that could be indicative of a greater danger to the health of the
substance. The drug inspectors will draw samples from various therapeutic
categories, different formulations, and various manufacturers from one retail
outlet using identified risks that include around 20 mentioned in the guideline
like the feedback of the various stakeholders such as healthcare professionals
and consumers the sampling schedule provided from the CDSCO for specific
therapeutic categories of medications in particular months, the use of certain
warnings about drugs issued by the CDSCO and state drug agencies for details of
the frequent not of Standard Quality or spurious drugs as well as their
production and sale outlets, and many more.
The Drugs Inspector will ensure that at a minimum, all of
the risks mentioned above are considered in his sampling efforts over six months. Additionally, no greater than 3 samples may be collected
from a single outlet, and the excess sampling in the event of any reason, must
be documented and approved by the authority controlling the sampling. The
guideline also outlines the criteria used to choose the place of sampling.
Each drug inspector should take at least 10 samples per month, comprising nine samples of drug – the active ingredient, as well as excipients, and formulations, as well as one sample of medical devices or cosmetics.
In such instances, the sample may be divided into two equal
parts, preferring with secondary or primary labels (one portion to be used by
the government analysts and the other for production in the court) and the
remaining two portions to allow for less testing. The data should be
documented in the appropriate forms as per Drugs, Cosmetics & Medical
Devices Rules and a covering letter addressed to the appropriate Government
Analysts if the samples are sent for testing for testing at a
lower level i.e. identification and assay only because of not being able
to get the full amount and it is added.
The guideline further states that the inspector of drugs
should design the sampling process in that the samples are sent to the
laboratory the day after sampling, or the next day if there are delays due to
transport from distant or rural locations.
The Drugs Inspector must determine the method of analysis
and working standards/references from the manufacturer of samples of patent and
proprietary drugs as well as new drugs, and not wait for the laboratory to
communicate and will provide them to the laboratory for prompt testing of the
drug. The NSQ and other spurious reports must be submitted to the CDSCO by
the 10th of every month to be uploaded on its website.
Each Drug Inspector will keep information on sampling,
including the number of samples collected and their processing completion up
to the report of the test as well as the number of NSQs that are reported by
laboratories and the actions taken and cases of false substances reported by
the laboratory in the report of test. The inspector must send the data to
the authority controlling them every month to enable the implementation of
their sampling program. The information gathered from the monthly sampling
data will be used to plan the next month’s sampling schedule.
“Each Drug Controlling office shall prepare a list every month for Wholesale/retail outlet with the name of the registered pharmacist
and owner where spurious products are reported/ distribution chain is broken
for the provided invoice. The above list shall be shared with their head office
for preparation of a centralized list of wholesaler/retailer outlets revealed
in the sale/distribution of spurious products and to give wide publicity for the
public to avoid the use of purchased medicine from these outlets,” stated the
guidelines.
In the past, The drug regulator has observed that there isn’t
a defined method for selecting samples, the location of sampling, etc. It was
carried out randomly based on the knowledge of individual Drug Inspectors.
“Often it was seen that sampled drugs are from big brands
and collected from urban locations or sub-urban locations only. The interior
locations or rural distributions are not covered and thereby quality of drugs
at distant users/last users was not being assessed. Cosmetics samples were not
collected in some regions. There is no centralized database of sale outlets
where NSQ/spurious products were reported, such identified outlets are to be
kept for regular vigilance,” the report added.
Sections 22 and 23 of the Drugs & Cosmetics Act 1940
specify the precise method for samples to be obtained by Drug inspectors
from Central and State Drug Control as part of the routine drug quality
surveillance. Drug sampling is a cost-effective job and resource
limitations could limit the number of samples taken, the methods that are used
to analyze, or the number of Drugs Inspector & Laboratory available to
perform the sampling and analysis as well. It is, therefore, crucial to make
the most of the resources, focusing on the parameters that pose a greater
risk for patients, and to apply risk analysis when planning the sampling, as
per the guidance.
It is worth noting that the 62nd session of the Drugs
Consultative Committee (DCC) is calling for a unified procedure in the country
to take rapid actions about the distribution of information, and the
suspension, or cancellation of a license for the sale of counterfeit
products. In the course of the meeting it was agreed that all States have
agreed to share information on the non-standard good quality (NSQ)
products as well as products with spurious ingredients each month, but
preferably by the 10th of each month.