Context: This article is based on the news “‘Fake’ drugs row: Directorate of Vigilance asks health department to withdraw drugs that failed tests” which was published in the Economic Times. The Directorate of Vigilance of the Delhi government has written to the health department to withdraw the drugs that failed quality standard tests.

The Rise of Counterfeit Drugs in India: A Major Public Health Threat

• Supply of Sub-Standard Quality Drugs: Lieutenant Governor of Delhi recommended a CBI inquiry into the matter of the alleged supply of drugs that failed quality standard tests and have the potential to endanger lives in Delhi government hospitals.
• Sub-Standard Quality Drugs: The drugs that were found to be of sub-standard quality drugs included:
  • Cephalexin: Critical life-saving antibiotics used for the treatment of lung and urinary tract infections.
  • Dexamethasone: A steroid for curing life-threatening inflammation in the lungs, joints and swelling in the body. 
  • Levetiracetam: Anti-epilepsy and anti-anxiety psychiatric drug. 
  • Amlodipine: Anti-hypertension drug 
• Counterfeit Drugs Sieze: Recently, counterfeit drugs of about ₹2 crores from leading manufacturers were seized from unlicensed premises situated in Kolkata.
• Spurious Drugs Circulation: Globally and in India, the pharma industry has been grappling with issues related to counterfeit or spurious drugs for a while now. However, these have been amplified post the pandemic.
  • In terms of volume, India’s pharmaceutical industry ranks third in the world. However, there have also been multiple incidents of counterfeit drugs and medication  hitting the market. 

Also Read about Generic Medicines, here. 

About Counterfeit Drugs

• Counterfeit Drugs: Drugs manufactured or packaged fraudulently are referred to as counterfeit/fake/spurious/falsified drugs because they either lack active ingredients or have incorrect dosages. 
• Global Issue: The World Health Organization states the frightening figure in which almost 10.5% of the medications worldwide are either subpar or fake. 
  • Although developing and low-income countries are the targets of large-scale drug counterfeiting activities, these drugs are also making their way into developed nations, including the USA, Canada, and European countries. 

About India’s Pharma Industry 

• Pharmacy of the World: India is known as the “pharmacy of the world” due to the low cost and high quality of its medicines.
  • India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. 
• Global Leader: The Indian Pharmaceutical industry is currently ranked 3rd in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. 
  • Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in the UK. 
  • Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. 
• Compliant with USFDA: India has the most number of pharmaceutical manufacturing facilities that are in compliance with the US Food and Drug Administration (USFDA) and has 500 active pharmaceutical ingredients (API) producers that make for around 8% of the worldwide API market.
• Future Prospects: According to a recent EY FICCI report, as there has been a growing consensus over providing new innovative therapies to patients, Indian pharmaceutical market is estimated to touch US$ 130 billion in value by the end of 2030.

How are drugs regulated in India?

• Drug Cosmetics Act 1940: The Drug & Cosmetics Act was passed to oversee medication imports into India, ensuring that no substandard or counterfeit drugs enter the country.
• Drug and Cosmetics Rules, 1945: These rules categorized the drugs into schedules and provided regulations on the sale, storage, and prescription of each category.
  • Schedule M: It is a part of the Drugs and Cosmetics Rules and explains the detailed requirements for manufacturing and quality control of medicines.
• Central Drugs Standard Control Organisation (CDSCO)
  • Nodal Ministry: Ministry of Health & Family Welfare, Government of India.
  • It is the National Regulatory Authority (NRA) of Drugs in India. 
  • Functions:
    • CDSCO is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, and control over the quality of imported Drugs in the country.
    • CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical Drugs such as blood and blood products.
• Good Manufacturing Practices (GMP): They cover things like the design of the manufacturing facility, training of employees, and quality control procedures.
• Drugs and Cosmetics Act: It controls the import, production, distribution, and sale of export pharmaceutical products and cosmetics.
• Pharma Export-Import Laws and Regulations: These rules include getting the required Importer-Exporter Code (IEC) and following export documentation requirements.

Continue Reading: India Pharma Products And Drug Safety

Counterfeit Drugs: Challenges to Eliminate Them

• Complexity of Scale of Manufacturing: The domestic pharmaceutical industry of India is a network of around 3,000 drug companies and nearly 10,500 manufacturing units. The monitoring of the quality of the ingredients at every stage of the value chain is not easy. 
• Complexity of Supply Chain: Manufacturing of a drug right from the beginning to the latter stages of marketing, distribution and sale involves not only a large number of ingredients and materials but also a large number of players, including suppliers, packaging and logistics entities, wholesalers and distributors, retailers and even resellers. 
  • This fragmented ecosystem opens the way for several points of entry and exit which leaves the material susceptible to adulteration, contamination or usage of substandard type, and the process likely to be compromised.
• Lack of Testing Facilities and Monitoring Personnel: India lacks an adequate number of testing facilities and inspectors and monitors. 
  • According to reports, under the National Good Laboratory Practice programme, India has only 47 drug testing facilities and six central labs, testing just 8,000 samples per year. Moreover, the country has only 20-30 test laboratories that can affirm whether a drug is counterfeited, authentic or of relatively poor make. 
  • India is severely understaffed in terms of numbers of drug inspectors and is yet to fulfil the Mashelkar Committee’s recommendation of having one drug inspector for every 50 manufacturing units and one per 200 distribution retailers.
• Dented Image: India is known as the ‘pharmacy of the world’, but that image has been dented by the death of around 18 children in Uzbekistan last year after they consumed an Indian-manufactured cough syrup. 
  • India has launched an investigation into these deaths of 18 children in Uzbekistan 
• Supply Chain Disruptions: During the COVID-19 pandemic induced supply chain disruptions, incidents of substandard and falsified medical products increased by almost 47% from 2020 to 2021. 
  • The  COVID-19 pandemic fuelled the demand for certain categories of medicines such as antipyretics, remdesivir, corticosteroids, vaccines, etc., thus increasing the demand and manufacture of fake medicines.
• Public Health Concerns: Substandard products across the pharma industry have a high potential for life-threatening damage. In addition to increased morbidity and mortality, counterfeit products might also worsen drug resistance and lead to treatment failure. 
  • The World Health Organisation (WHO) estimates that there are over 1 million deaths per annum from substandard and counterfeit drugs, causing $21 Billion of global financial impact. 
• Counterfeits Affecting Pharma Growth: Counterfeit drugs and their circulation tend to prove detrimental to the growth of the pharma industry, which can only flourish based on quality and trust. 

Counterfeit Drugs: Steps Taken to Eliminating Them

• Task Force for Providing Solutions: The Indian government formed a task force to tackle the issue of drug counterfeiting. The task force ultimately concluded that for track and trace to be effective, the following two systems must be implemented concurrently: 
  • A unique identification number for each primary pack allows consumers to identify the medicine. 
  • A 2-D barcoding that incorporates all product information for quick data retrieval at each stage of the supply chain.
• The Indian Government’s New Barcode Regulation: Mandatory application of barcodes or QR codes to the packaging of India’s leading 300 medicine brands. 
  • The new rule demands pharmaceutical companies to strictly adhere to this unique product identification system, with non-compliance leading to hefty penalties. 
  • These barcodes will contain crucial information, including the drug’s name, brand name, the manufacturer’s details, batch number, manufacturing and expiry dates, and the manufacturing license number.
• Legislative Measures: India has provisions under intellectual property law (The Trademark Act, 1999 and The Patents Act, 1970) to punish the drug counterfeiters.
• Measures Undertaken by WHO: WHO further launched a project on counterfeit drugs in 1995. Further, in 2006, the International Medical Products Anti-Counterfeiting Taskforce was established by the WHO, and it has since become the primary vehicle for the organisation’s efforts to combat fake drugs.

Way Forward to Combate Counterfeit Drugs

• India as World’s Pharmacy: To further bolster India’s image as the “Pharmacy of the World”, all stakeholders must work together to ensure issues such as counterfeit drugs do not dent this image. 

• Pharmaceutical products contribute around 8% to India’s overall merchandise exports and 2% to India’s gross domestic product (GDP). Safeguarding India’s image as a trusted, reliable supplier of pharmaceutical products is imperative to realise India’s ambition of ‘Atmanirbhar Bharat’.
• Role of Various Stakeholders in Protecting Against Counterfeiting of Drugs: Role of the Consumers, Pharmacists, Pharmaceutical Companies and  Regulators to ensure that their people receive genuine medicines. 
  • For instance, based on the recommendations of the task force, India has implemented the suggestion of including a unique identification number and a bar code on each drug pack. One can verify the authenticity by sending the unique code behind the bottle or package to the Drug Technical Advisory Board’s (DTAB) number via SMS. 
• Utilising Technologies to Prevent Drug Counterfeiting: Technology must be adopted at all levels of the value chain keeping an eye on material and ingredients used at every step. 
  • For example, track and trace technologies marked by mass serialization of pharma products with barcodes, RFIDs and holograms, along with tamper-evident seals, must increasingly become standard practice. 
• Utilising Blockchain Technology: Blockchain technology uses a decentralised peer-to-peer architecture for transaction processing with little potential for record-tampering. 
  • This would make it possible to maintain a permanent record of all transactions that will be accessible to all the parties involved and include details such as location, data, quality, and pricing. 
  • Implementation of blockchain technology in the supply chain will help to make it safe, transparent and decentralised, thus enabling savings in expenditure while ensuring the ability to track down doubtful areas and close any gaps in the supply chain of genuine drugs. 
• Awareness Campaigns: There should be a country-wide campaign to make patients and lay people aware of the risks and the precautionary steps that they must take to verify the authenticity of medicines that they would procure.

Conclusion

The fight against counterfeit drugs in India demands a comprehensive approach, combining legislative measures, technological innovations, and heightened awareness to safeguard public health and uphold the nation’s reputation as the “Pharmacy of the World.

DOWNLOAD PDF