Tackling substandard drugs: Central drug regulator issues draft standard operating procedure

New Delhi, June 2017:

To remove ambiguities related to quality testing of drug samples across the country, the Central Drugs Standard Control Organisation (CDSCO) has decided to take a first step in that direction by issuing a draft “standard operating procedure (SOP) for handling of not of standard quality (NSQ) samples” through a three-tier testing process.

“Whenever the analysis result of any sample is not within the range of specified limits, it is referred to be not of standard quality (NSQ)/ Out of Specification (OOS). Such a sample has to go through certain set of procedures. On getting an OOS, the analyst immediately reports the OOS to head of department or the authorised person. All the solutions or the standards used during the testing should be preserved,” the draft SOP stated. The final SOP would be formed after the CDSCO receives all the comments from stakeholders by July 12, 2017.

India has neither a nation-wide drug recall system in the country nor any rules mandating the companies to withdraw “substandard” drug batches from the market. Moreover, India has 36 drug regulators. There is one central drug regulator which is known as Central Drugs Standard Control Organization (CDSCO) and the remaining 35 are drug regulators of various states and Union territories. Each of the 36 regulators continuously keep testing the drugs, manufactured and sold in the country, on various quality parameters. The draft SOP is a step in the direction to streamline these testing process across the country.

“HOD/authorised person would review the results reported by the first analyst and investigate the error if any. Error may occur during preparation/ handling of samples like improper weighing of sample, loss of sample due to spillage, error in dilution, error in preparation of reagents and solutions or due to any testing instrument malfunctioning. Authorised person would allot the sample to another or senior analyst (as per the availability) for retesting,” the draft SOP added.

Here, the retesting refers to the analysis of the original homogeneous/remaining portion of the sample. “After second analysis, the sample either complies with or does not complies with the specification applicable. If the sample does not complies with the specification and the results match with the results of the first analysis within plus or minus 2 per cent, then the higher value will be reported and the sample is declared ‘not of standard quality’,” the draft SOP stated.

The draft SOP has been formed by the CDSCO as per the recommendations of Drugs Consultative Committee (DCC) and the stakeholders — pharmaceutical companies, chemists, common public, etc — have been asked to submit their comments or suggestions by July 12, 2017. The DCC, which plays an advisory role to the CDSCO and the health ministry, gave the recommendations related to handling of NSQ drugs in November last year.

According to the draft SOP, during the second analysis, if the sample does not comply with the specification and the results do not match with the results obtained during first analysis, then the sample would be sent for third analysis. If the results of the thrid analysis match with the results of the first analysis within plus or minus two per cent, then the higher value of the two would be reported and the sample would be declared NSQ.

However, the SOP stated that if the third analysis results are same as that of second analysis results within plus or minus two per cent, the sample would be declared as of standard quality.

“After the completion of retesting, if the test sample is found NSQ, the HOD/Authorised person will review and investigate the complete analysis/procedure and prepare a final investigation report as per a specified format. The test report would be sent to a government analyst/director for final approval and release. All the data for initial testing, retesting and investigation is retained with the report. In case of NSQ drugs, the report has to be reported or uploaded on the website within 24 hours of completion of its testing including review process,” the draft SOP stated.

An assay test checks for the presence of that substance and measures the exact amount of it. As per the Drugs and Cosmetics Act, 1940, each particular substance need to be present in the medicine in a specified amount. For example, in Ciprofloxacin+ Tinidazole, the Tinidazole has to be in the limit of 90 per cent minimum to 110 per cent maximum when compared to the claim made in the medicine’s label. If it breaks the limit, it is considered as NSQ/OOS. Just like this assay test, different tests are done to check for NSQ drugs.

According to a report dated November 28, 2016, of The Indian Express, in a major crackdown since March, 2016, the drug regulators of seven states found that 27 medicines — sold by 18 major drug companies in India — were of ‘substandard’ quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.

Of the 18 companies, only two said they had stopped sale of the affected drug batches and just one said the affected batch had been recalled. The tests on the 27 medicines were done by regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh.