Reforming the sampling and testing protocols under the Drugs & Cosmetics Act

Continuing with our campaign to improve the quality of drugs in India, we recently sent another petition to the Ministry of Health asking for a relook at the sampling and testing protocols followed by Drug Inspectors and Government Analysts under the Drugs & Cosmetics Act, 1940. The petition can be accessed here. The Drugs & Cosmetics Act establishes  a procedure for the sampling and testing of drugs drawn from the market in order to monitor the quality of drugs being sold across India. This sampling begins with Drug Inspectors in every district drawing samples from pharmacies after tendering a fair price for the drug. Such samples are required to be sealed in a specified manner before being sent to Analysts in government laboratories for testing. As per the Second Schedule to the Drugs & Cosmetics Act, these drugs are required to be tested against the standards laid down in a recognized pharmacopeia mentioned on the labeling of the drug.

A pharmacopeia basically consists of monographs which prescribe standards and testing methods for virtually every drug that is sold in the Indian market. Most Indian pharmaceutical manufacturers abide by the Indian Pharmacopeia (IP) which is an official publication of the Indian Pharmacopeia Commission (IPC). However manufacturers can also choose the British Pharmacopeia (BP) or the United States Pharmacopeia (USP) if a monograph does not exist in IP.  

Once the Government Analyst completes testing of the sample sent by the Drug Inspector, the test report is sent back to the Drug Inspector. If the report indicates that the sample has failed testing, the Drug Inspector can initiate prosecution against the pharmaceutical manufacturer and even the pharmacist, provided the head of the state drug administration gives a sanction to initiate such prosecution. A drug sample can fail the testing process for a number of reasons. If the sample fails to match the standards mentioned in the IP, the manufacturer can be prosecuted for selling a product not of standard quality. This is the most common offence under Indian law. Others include prosecution for selling misbranded, spurious or adulterated drugs – each of these are well defined in the Drugs and Cosmetics Act.  

 There are several problems with the manner in which drugs are sampled from the market by the Drug Inspectors and the manner in which the Government Analysts conduct the testing for these drugs in the government laboratories.

As we state in our petition, the first problem with the sampling process “… is the complete absence of any scientific sampling guidelines to guide Drug Inspectors on the kind of drugs, location of sampling and the type of manufacturers that should be the focus of sampling.” Ideally, the sampling should be based on some scientific statistical modeling but that does not appear to be the case. For most part, the Drug Inspectors appear to randomly draw samples from the market depending on budget provided to them. Such random sampling does not provide an accurate representation of the drug supply chain in the market from where drugs are being drawn by the Drug Inspector.

The second problem as mentioned in our petition is that the “current mode of drawing samples from the market is the statutory insistence, in Section 23, on the Drugs Inspector drawing only 3 or 4 samples of which only 1 sample is sent to the Government Analyst for testing. The success or failure of merely 1 sample out of an entire batch (which could be anywhere between 500 to 2000 units) is statistically irrelevant in our opinion and does not really provide enough information to conclude the robustness or otherwise of the manufacturing process followed by a pharmaceutical company.”

Regarding the issue of testing of these drugs by Government Analysts, we argue in our petition that merely testing drugs as per the IP is inadequate to ensure the quality of our drug supply. Even the IP notes that “Pharmacopoeial methods and limits should be used merely as compliance requirements and not as requirements to guarantee total quality assurance”. We believe that the only way to conduct a comprehensive quality check is to complement the testing of drug samples in government laboratories with a dedicated audit of the batch records at the manufacturer’s facility in order to assess whether the pharmaceutical company has complied with mandatory batch release testing, as specified in Schedule M. This does not appear to be happening with any regularity in this day and age.

Another specific concern with regard to testing is the failure to test for impurities contained in drugs being sold to patients. From the test reports that we examined, it is quite clear to us that Government Analysts test only for assay, dissolution and at times, for microbiological contamination and sterility. However when it comes to tablets, we have seen several test reports where a tablet is found to be discoloured with brown or black particles. These brown or black particles are most likely due to impurities resulting in degradation of unstable drug formulations. A testing process however cannot depend only on visual examinations. Rather it should depend on scientific methods like liquid chromatography or spectroscopy to detect even those impurities that are not visible to the naked eyes. We therefore recommend an overhaul of the testing protocols to go beyond the IP.      

Our third concern with testing protocols followed in government laboratories are the manner in which fixed-dosed-combination (FDCs) are tested in government laboratories. As is common knowledge now, most  FDCs on the Indian market have entered the market in an illegal manner.   It follows that most of them do not have a monograph in the IP. Nevertheless these drugs continue to be sold despite a few hundred of them being banned. When these drugs are drawn from the market for testing their quality and there is no monograph in the IP, the Government Analyst writes to the manufacturer asking it to provide a testing protocol for the FDC. These companies do provide a testing protocol but unlike the monographs in the IP, these protocols are not rigorously validated. As a result, it is not surprising when Government Analysts report that some of these testing protocols do not work in practice. This method of testing wherein manufacturers provide testing protocols that have not been rigorously validated does not inspire confidence in the quality of testing protocols and is similar to the fox guarding the hen-house. To conclude, our petition asks the government to setup an Expert Committee to study the manner in which sampling and testing takes places under the Drugs & Cosmetics Act, 1940. The current mode of sampling and testing was laid down as far back as in 1940 and is outdated in the 21st century.  

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