India is not a country that is new to making claims and taking actions that vehemently oppose the selling of fake and contaminated pharmaceuticals. The Indian pharmaceutical sector was expanding rapidly after the Drugs Act was passed in 1940. Unfortunately, few in the government were concerned with the standard of pharmaceuticals and their regulation.
The Mashelkar Committee, chaired by Dr. R.A. Mashelkar, was established in 2003 to investigate all areas of the regulatory architecture as well as the amount and problem of counterfeit / inferior medications in the country. Regrettably, the Indian pharmaceutical industry experienced its first significant crisis with Ranbaxy in 2006. So, it's critical to comprehend why drugs of poor quality are hazardous and perhaps fatal.
What is meant by a NSQ drug?
In very simple words when the quality of drugs fails quality tests, standards and specifications set for them by national or international standards termed as NSQ drugs. (Johnston A & Holt D, 2013) ( In case of tablets, when it fails the assay test ( determine the amount of active ingredient in a tablet) & dissolution and the disintegration test.
Why an assay test is important?
The amount of the tablet's active ingredient is determined using an assay test. When an active ingredient in a tablet is lacking, it can have a negative impact on one's health and, in certain cases, even cause death. Most drugs which are labeled as NSQ drugs falls in this category.
What are dissolution & disintegration tests?
These tests assess a tablet's capacity to dissolve in the bloodstream. Thus when a tablet lacks these quality, they have no therapeutic effect on a patient and can also be harmful to their body.
In case of vaccinations there are 'sterility' test is performed to see it should be free of contamination like presence of glass particles, bacteria or other microorganisms which again results in severe illness.
The Drugs and Cosmetics Act of 1940 mandates a minimum of one year in prison and a maximum of two years in prison, with a modest fine of Rs. 20,000 for the manufacture and sale of NSQ drugs. In some special circumstances, there is a mere detention till the rising of the court along with a fine of 70,000 rupees.
Non Adherence to Good Manufacturing Practice (GMP) in pharma world
The non-compliance with GMP, which mandates that a pharmaceutical company conduct quality control inspections at each stage of a drug's manufacture until it reaches the market, is the reason for the poor quality of drugs in India. GMP in India was incorporated into the Drugs and Cosmetics Rules 1945, in the year 1988.
The principal reason of India's low GMP compliance is the country's drug regulatory agencies' increased focus on market drug testing and surveillance. The phrase "market surveillance method" defines it. It means that the sampling of drugs is done by the states (not a wide cross-section sample) and some states do not have equipped labs and manpower to do the checks quite rigorously. State drug inspectors, who in India are mostly in charge of testing, in some cases, also don't disclose their sample method. This lead to further problems in recalling of drugs at a national level.
Findings from The National Drug Survey 2014-2016
The Extent of Issues of Spurious and Not of Standard Quality (NSQ) Medicines in the Country was the subject of a survey performed in 2014 by the Ministry of Health and Family Welfare (MoHFW), Government of India. National Institute of Biologicals (NIB) planned and carried out the survey with assistance from the Indian Statical Institute, MoHFW, and NABL (National Drug Survey, 2014-16).
State drug controllers functioned as nodal officers and coordinated sample collection and delivery to NIB out of 47,954 samples obtained under the survey by state and central drug inspectors.
The amount of NSQ and spurious drugs for government and retail outlets sources in India were calculated to be 3.16 percent and 0.024 percent, respectively. Mizoram, Nagaland, Meghalaya, Manipur, Tripura, Puducherry, Gujarat, and Punjab were on the higher side of the NSQ, while the Andaman and Nicobar Islands, Dadra and Nagar Haveli, Goa, West Bengal, Delhi, Jharkhand, and Kerala were on the lower side of the NSQ following the analysis of the retail stores.
In India, there were reportedly 10.02 percent of NSQ drugs coming from government supply chain. Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Telangana, Uttarakhand, Uttar Pradesh, and Punjab were among the states with NSQ values that were higher, while Chandigarh, Delhi, Orissa, Tamil Nadu, and West Bengal were among those with NSQ values that were lower.
The challenge with NSQ drugs will remain in India until and unless there is a strict adherence to GMP, robust law on recalling of NSQ drugs, strict guidelines for the drug inspector for drug sampling, and more transparency in publishing the entire list of drugs going for testing, auditing of state government labs among others. Most of the drugs which are manufactured in the states like Uttarakhand and Himachal Pradesh where is no excise fee imposed on them should be always kept in a radar for strict regulatory compliance.
Thakur, D. & Reddy, P. (2019). The Myth of Drug Regulation in India. Simon & Schuster India. The Truth Pill: The Myth of Drug Regulation in India - Dinesh Singh Thakur, Prashant Reddy Thikkavarapu - Google Books
Johnston, A., & Holt, D. W. (2014). Substandard drugs: a potential crisis for public health. British journal of clinical pharmacology, 78(2), 218–243. https://doi.org/10.1111/bcp.12298