CONTROL OF SPURIOUS DRUGS

Advertisements

Spread the love

Post Views: 1,376

This article is written by Ayni Saad Second year Law student, Faculty of Law, University of Delhi , an intern under Legal Vidhiya

ABSTRACT:

Right to Health is constantly been identified as one of the cornerstones of Right to Life which is a valuable fundamental right guaranteed to the Citizens under Article 21 of the Constitution of India, 1950.[1] Spurious Drugs are drugs whose formula conceal the real nature of the Product which resembles some other Drug and more particularly, a drug belonging to a Popular Brand. Such Drugs often deceive the purchaser and cash in on the popularity of the real brand. Hence, the availability of fake drugs affects not only the citizens’ health but also the foundation of their fundamental rights as protected by The Constitution of India, 1950.

The Central Drugs Standard Control Organization, which is part of the Indian Medicines Regulatory Authority, has declared spurious drugs to be not of standard quality (NSQ).

Key Words: Spurious drugs, right to health, not of standard quality, poor quality, regulations, genuine, counterfeit drugs, fundamental Right

INTRODUCTION: CONTROL OF THE SPURIOUS DRUGS

Spurious drugs can be produced by criminal organizations that seek to profit from the high demand for medications, especially in developing countries where regulations and enforcement may be weak. They can also be the result of poor-quality control in legitimate manufacturing facilities, or the result of storage or transportation issues that compromise the effectiveness of the medication.

Spurious drugs can be difficult to identify because they may look like genuine medications and even have convincing packaging and labelling. However, they can have serious consequences for patients, including treatment failure, drug resistance, and adverse reactions.

To reduce the risk of spurious drugs, it is important to purchase medications only from reputable sources and to check for proper packaging, labelling, and expiration dates. Governments and international organizations are also working to improve drug regulatory systems and strengthen enforcement to combat the problem of spurious drugs.

BACKGROUND:

False drugs can be distributed and have serious negative effects on patients, customers, and legitimate producers. The percentage of fake drugs in circulation is roughly 0.3%, according to the State Drug Controller. A thorough investigation was required to determine the true level of spurious drug circulation in the population at large due to the grave repercussions on public health associated with its circulation.

The data from 2000 to 2013 were acquired, analysed, and synthesised to present the real story of India’s inadequate access to medication. To lessen fake, counterfeit, wrongly branded, or medications of poor quality, more stringent regulation and legal action against the problem are urgently required. In order to protect and improve the health of the general populace, India has continued to put various preventative measures into place.

According to the findings of the Mashelkar Committee, the Committee turned in their report in November 2003.[2] The Committee had made various recommendations for amendments to the Medicines & Cosmetics Act’s criminal provisions in portion (B) of the Report. The following are the Committee’s primary suggestions: –

The enhancement of the penalty from life in prison to the death sentence for the sale and manufacture of fake pharmaceuticals that result in severe injury or death.
The sale and production of counterfeit medications, which are not anticipated to have the same effects as those listed in I above, should be deemed cognizable and non-bailable.
Those who are unable to provide proof of their purchase should be penalised.
Minor offences should be eligible for compounding, which would allow the prosecution to focus on more important matters in the proper courts while the little offences were quickly resolved.
Permission for the police to pursue legal action.
Establishing special courts to handle offences under the Medicines & Cosmetics Act in order to speed up the legal process.
Enhancement of jail sentences and penalties for certain offences, including the idea of damages.

ISSUES:

Lack of knowledge about the 1940, Drugs and Cosmetics Act among local government officials and the pharmaceutical business.
It has detrimental consequences on the consumer’s health.
Has an impact on the revenue and reliability of the product’s original maker.
Affecting the financial and economic frameworks of retailers, producers, and manufacturers.

PROVISIONS TO CONTROL SPURIOUS DRUGS

(A) THE 1940 DRUGS AND COSMETICS ACT:

The 1940 Drug and Cosmetics Act is the law enacted by government of India to modulate the import, produce, distribute, and vending of medicine and cosmetic in the nation. The act was revised several numbers of time to ensure safety and efficacy of the medicine and cosmetic sold in India.

In India, the 1940 Drug and Cosmetic act and also its amendments prohibit the production, vending, and distribution of the adulterated medicine. The Central Drug Standard and Control Organization (CDSCO) is responsible for enforcing these regulations and monitoring drug standard throughout the country.

Some of the essential features of the Drugs and Cosmetics Act are as follows:

Approval Process: The Act details the application process for cosmetics and pharmaceuticals. The Central Drugs Standard Control Organization (CDSCO) must approve all medicines and cosmetics before they may be marketed on the Indian market.

Classification of drugs: Over-the-counter (OTC) medicines and prescription pharmaceuticals are separated into separate categories under the Act. Prescription drugs can only be bought with a doctor’s prescription, but over-the-counter medicines can be obtained without one.

Labelling requirements: The Act lays out the requirements for labelling drugs and cosmetics. The label of the product must include a list of the product’s ingredients, usage guidelines, cautions, and hazards.

Quality control: The Act includes provisions for quality monitoring of medications and cosmetics. All cosmetics and drugs must meet these requirements, which are established for both categories of products.

Prohibition on advertising: The Act prohibits the advertising of certain drugs and cosmetics. Drugs that are likely to be harmful if not used under medical supervision cannot be advertised.

Penalties: The Act provides for penalties for violations of its provisions. The penalties can include imprisonment, fines, and cancellation of licenses.

The Drugs and Cosmetics Act has some of these key components. The Act strives to guarantee the safety and high quality of medicines and cosmetics sold in India.

DEFINITION OF SPURIOUS DRUGS:

Section 9B of the Drugs and Cosmetics Act of 1940 defines spurious drugs

If it is imported under a name that is associated with another medication
If the medicine’s label or container has the name of another drug without any resemblance to that other drug and is an imitation, substitution, or otherwise closely mimics another drug.
If the name of a person or business that represents the maker of the medicine is printed on the label or container, such person or business is fictional.
If another medicine or substance has been used in place of it completely or partially
If it falsely claims to be made by a company for whom it is not actually a product

The main objectives of the Drug and Cosmetic Act are to:

Ensure quality, safety, and efficacy of medicine and cosmetic.
Regulate import, production, distribution, and vending of medicine and cosmetic.
Establish a system for the inspection and license of production and vending facilities.
Define a legal framework for the labelling and packaging of drugs and cosmetics.
Create sanctions for breaking the Act’s rules.

The Act defines medicines and cosmetics as any products intended to improve one’s appearance or to diagnose, treat, or prevent disease. According to the Act, every medication and cosmetic sold in India must have a licence from the appropriate government and meet a number of effectiveness, safety, and quality standards.

A key component of regulation, the Medicines and Cosmetics Act, ensures the efficacy and safety of medications and cosmetics marketed in India. The Act is enforced by the Central Drug Standard Control Organization (CDSCO), which is in charge of managing the nation’s pharmaceutical and cosmetic sectors. The definitions, penalties, and legal procedures for all offences covered by the Act are outlined in Sections 13, 15, 16, 17(A&B), 19 27 and 36AC of the Drug and Cosmetics Act of 1940.[3]

(B) THE DRUG AND COSMETICS (AMENDMENT) ACT, 2008:

When acting on medication samples that were discovered to be fake or of subpar quality, it is important to follow certain standards specified by the Drug and cosmetics (Amendment) Act, 2008.[4] Also, it introduced dissuasive penalties for offences involving the production of fake or contaminated medications, which have gravely detrimental consequences on the general public’s health. The Amendment Act also separated the low-quality drugs into three categories. Here is a list of them:

Category A (The Spurious and Adulterated Drug):

Adulterated drug refers to drugs that have been tampered with or modified in a way that makes them unsafe for human consumption. This can include the addition of other substances or the removal or substitution of active ingredients.

Each stage of the production process, from acquiring raw materials to packing and labelling finished items, is susceptible to drug adulteration. Adulterated drugs can be harmful and can lead to serious health problems, including death.

Category B (Grossly sub-standard drugs)

Grossly substandard drugs are medications that do not meet the quality standards established by regulatory agencies. These drugs may contain insufficient amounts of active ingredients, or they may be contaminated with harmful substances such as bacteria, heavy metals, or other impurities.

Category C (Minor defects)

Grossly substandard drugs can pose significant risks to patients, including treatment failure, drug resistance, adverse reactions, and even death. They can also undermine public confidence in the healthcare system and contribute to the spread of drug-resistant diseases.

Medication made by licenced manufacturers was shown to have deficiencies stemming from minute quality variations. Such faults may be the consequence of inadequate pre-formulation research investigations, a manufacturer’s lack of process controls, or inadequate pharmaceutical storage or transit conditions. For instance, tablets with cracks or chips, stains, a discoloured or uneven coating, a change in the colour of the formulation, etc.

(C) THE TRADE MARKS ACT, 1999:

The Trademarks Act of 1999’s Sections 9(a), 11, 134(b), and 135 offer civil and criminal penalties for trademark infringement, generally based on the chemical ingredient employed in the medicine that prevents the brand from being naturally recognisable. False trade names and trademarks are likewise punishable under the Act.[5]

An essential clause pertaining to the registration of well-known trademarks in India is Section 9A of the Trademarks Act, 1999. This section’s major goal is to provide well-known trademarks extra protection and to stop others from using them without authorization.

Here are some key features of Section 9A:

Definition of well-known trademark: A well-known trademark is one that has developed a strong reputation in India or any other nation via use or promotion, according to Section 9A.

Recognition of well-known trademarks: On an application submitted by the trademark holder, the Registrar of Trademarks has the authority to classify a trademark as a well-known trademark.

Factors for determining well-known status: When evaluating whether a trademark is well-known or not, the Registrar is expected to take into account a number of different elements. These elements include how long, how widely, and where a trademark has been used, how much exposure and advertising it has received, and how well-known it is among the relevant segments of the public.

Protection of well-known trademarks: A trademark is entitled to increased protection under the Trademarks Act once it is acknowledged as a well-known trademark. When it comes to products or services that are not comparable to those for which the trademark is registered, the trademark owner has the right to restrict the use of the trademark or any similar marks.

Grounds for opposition: A trademark might be challenged for registration on the grounds that it is a well-known brand. The resistance may be based on the trademark having been used, registered, or recognised as a well-known brand in India or another nation.

Generally speaking, well-known trademarks, which are regarded as valuable assets for enterprises, are protected in a significant way under Section 9A of the Trade Marks Act. By identifying and defending these trademarks, the law works to safeguard their goodwill and reputation while preventing consumers from being duped or confused by the use of identical marks by third parties.

Section 11:

The grounds for the Registrar of Trademarks’ rejection to register a trademark are outlined in Section 11 of the Trade Marks Act, 1999. A trademark cannot be registered in India under a number of different situations, which are listed in the section.

The main reasons for Section 11 denial of registration are listed below:

Identical or similar trademarks: A trademark cannot be registered if it is the same as or nearly identical to an earlier trademark that is already registered in India for comparable products or services.
Descriptive trademarks: A trademark cannot be registered if it just includes of words, names, symbols, or other visual representations that indicate the features or calibre of the products or services.

Non-distinctive trademarks: A trademark cannot be registered if it cannot identify the products or services of one person from those of another.

Deceptive trademarks: A trademark cannot be registered if it is likely to mislead or confuse consumers.

Scandalous or obscene trademarks: A trademark that is scandalous or obscene cannot be registered.

Prohibited marks: A trademark cannot be registered if it contains any elements that are forbidden under the Emblems and Names (Prevention of Improper Use) Act, 1950.

Geographical indications: A trademark cannot be registered if it incorporates any geographical indications covered by the Geographical Indications of Goods (Registration and Protection) Act, 1999.

In general, Section 11 of the Trade Marks Act is a crucial clause that supports the integrity of India’s trademark registration procedure. The section makes sure that only unique and legitimate trademarks are registered in the nation by outlining specific grounds for rejection of registration, safeguarding the interests of both trademark owners and consumers.

Section 135: of the Trade Marks Act, 1999 covers the offences and punishments associated to using a fake trademark, selling or possessing products with a false trademark, and falsifying a trademark.

Here are the key provisions of Section 135:

Falsification of a trademark: With the purpose to mislead or create confusion, anybody who creates a fraudulent trademark or attaches a false trademark to products or services is guilty of a crime.

Sale or possession of goods with false trademark: Anyone who, with the aim to deceive or to create confusion, sells, distributes, or has in their possession any products or services for sale or distribution bearing a fake trademark is guilty of an offence.

Punishment: These violations are punishable by imprisonment for a minimum of six months and a maximum of three years, as well as a fine. The sentence may be up to six years in jail for a second or subsequent crime.

Cognizance of offences: These offences are cognizable, and a police officer with at least the sub-inspector level can investigate. Only a complaint from the Registrar of Trademarks or another person designated by him would allow the court to take cognizance of the violations.

Protection of action taken in good faith: Nothing done or intended to be done under this Act in good faith shall give rise to a lawsuit or other legal action against any person.

Overall, Section 135 of the Trade Marks Act is a significant measure that works to prevent trademark misuse and imposes penalties on those who do. The clause serves as a deterrent against trademark fraud, which can confuse customers and damage the reputation of legitimate trademark owners.

(D) THE INDIAN PENAL CODE, 1860:

According to the Indian Penal law, 1860, anybody who tampers with drugs or medical preparations in order to reduce their effectiveness or alter how they work in order to use or sell them for medical purposes would be punished under the law.[6]

Section 274:

Section 274 of Indian Penal Code (IPC) deals with the offence of adulteration of drugs. Adulteration of drugs refers to the process of adding or mixing any harmful or foreign substance with a medicine or drug to increase its quantity or to make it look more genuine.

Here are the key provisions of Section 274:

Adulteration of drugs: Any person who tampers with drugs or medical substances with the aim to hurt others or with knowing that such tampering is likely to do so is guilty of an offence.

Punishment: The penalty for violating Section 274 is either a fine or a sentence of jail that may last up to 10 years. If a person suffers severe harm as a result of a drug’s adulteration, the penalty might be life in prison.

Cognizance of offences: A police officer not below the level of a sub-inspector may conduct an investigation into the offence under this provision since it is cognizable. Only after receiving a complaint from the Drug Inspector or another authorised authority may the court declare an infraction to have occurred.

Protection of action taken in good faith: Nothing done or intended to be done under this section in bad faith shall give rise to a claim or other legal action against any person.

Overall, Section 274 of the IPC is a significant provision that aids in the fight against medication and medicinal substance adulteration, which has the potential to seriously impair the public’s health. The clause imposes harsh penalties on individuals who engage in such behaviour, acting as a deterrent and assisting in maintaining the safety and efficacy of medicines on the market.

RELEVANT CASE LAWS:

1. Union of India vs. Ashok kumar Sharma:

The landmark case involving the sale of bogus medications in India is Union of India v. Ashok Kumar, popularly referred to as the “fake drug case.” The CBI inquiry found that Ashok Kumar Sharma, the proprietor of Pure Pharma, has long been involved in the production and distribution of counterfeit medications. The labelling and packaging of the pills were the same as those of the real pharmaceuticals, and they were sold under the brand names of well-known pharmaceutical corporations.

Following Ashok Kumar Sharma’s arrest, charges were brought against him under many sections of the 1940 Drugs and Cosmetics Act and the Indian Penal Code. After a trial, Ashok Kumar Sharma was determined to have manufactured and sold phoney medications. He received a life term in jail and a fine of Rs. 2 lakh.

In 2008, the Supreme Court of India upheld the conviction and sentence of Ashok Kumar Sharma. The court observed that the manufacture and sale of fake drugs was a serious offence, as it had the potential to cause harm to people’s health and could even be fatal. The court also noted that the penalty for such offences should be severe, to act as a deterrent to others.

2. Bayer Corporation and Others vs Union of India and Others

A significant case involving India’s patent laws is Bayer Corporation and Others v. Union of India and Others. A patent was owned by Bayer Corporation and its affiliate, Bayer Intellectual Property GmbH, for the cancer medication Sorafenib Tosylate. Nexavar was the trade name of the medication, which was used to treat liver and kidney cancer.

In order to make and market a less expensive generic version of the medication, the Indian government awarded Natco Pharma, an Indian generic medicine company, a compulsory licence in 2012. Section 84 of the Indian Patents Act, which permits the government to provide licences to produce and market generic copies of protected medications under specific conditions, was used to give the forced licence.

At the Intellectual Property Appellate Board (IPAB), Bayer Corporation contested the granting of a compulsory licence. The IPAB, however, affirmed the government’s choice to provide the required licence.

Bayer Corporation then filed a writ petition in the Bombay High Court challenging the IPAB’s decision.

Decision:

The Bombay High Court affirmed Natco Pharma’s issuance of a compulsive licence in 2014. The court noted that the compulsory licence was issued in the public interest since it would make the life-saving medication more affordable for patients.

The Bombay High Court’s ruling was subsequently contested by Bayer Corporation in a special leave appeal to the Supreme Court of India. However, in 2018, the Supreme Court denied the appeal and affirmed Natco Pharma’s award of a compulsorily issued licence.

The Bayer Corporation and Others v. Union of India and Others case, in which the Supreme Court rendered a ruling, was noteworthy because it reinforced the Indian government’s commitment to expanding access to affordable healthcare throughout the nation. The decision also made clear the necessity for a fair approach to patent laws that considers both the interests of patent holders and the general public.

Brahmaji Vs. state of U.P. & others

The whistle-blower system was introduced in Brahmaji V/s state of U.P. & others to reward those who report the discovery of fake pharmaceuticals.[7]

A ten-year minimum sentence with a life sentence option and a minimum fine of ten lac rupees—or three times the number of drugs seized—whichever is higher—replaces the prior provision that called for a minimum sentence of five years with the possibility of life in prison and a minimum fine of 10,000 rupees.

Allergen Inc. Vs. Sun Pharmaceuticals Industries Ltd.

According to the decision in the case of Allergen Inc. v. Sun Pharmaceuticals Industries Ltd., there can be no doubt that the greatest care should be made to prevent any doubt in the customer’s mind regarding the actual product that he is consuming.[8]

Novartis AG Vs. Union of India

The Supreme Court concluded in Novartis AG v. Union of India that the Patent Act of 1970’s genuine legislative provision was to allow true inventions relating to medical ingredients while also forbidding multiple patents on chemical compounds based on bogus grounds.[9]

SOLUTIONS AND SUGGESTIONS

The control of spurious drugs is a compound and complicated matter that requires the cooperation of the governments, regulatory bodies, pharmaceutical companies, healthcare providers, and the public. Here are some measures that can be taken to control spurious drugs:

1. Strengthen regulatory systems: Governments should establish and enforce strong regulations and standards for the production, import, distribution, and sale of medications. This can include increased inspections of drug manufacturing facilities, stricter licensing requirements for pharmaceutical companies and distributors, and tougher penalties for those who engage in illegal activities.

2. Improve supply chain management: Efforts should be made to improve the traceability of drugs throughout the supply chain, from manufacturers to end-users. This can involve using technologies such as barcoding, RFID, and blockchain to track the movement of drugs and prevent counterfeit products from entering the system.

3. Increase public awareness: Patients should be educated about the dangers of spurious drugs and the importance of purchasing medications from reputable sources. Healthcare providers can play a key role in raising awareness among their patients and promoting safe medication practices.

4. Collaborate with international organizations: Governments and regulatory bodies can work with international organizations such as World Health Organization (WHO) and Interpol to share information and coordinate efforts to combat the production and distribution of spurious drugs.

5. Support research and development: Efforts should be made to develop new technologies and tools to detect spurious drugs and improve drug quality control. This can involve investing in research and development, providing incentives for pharmaceutical companies to prioritize drug safety and quality, and supporting innovation in the pharmaceutical industry.

CONCLUSION

Misbranded and poor quality of drugs affects the society at large as medications consumed by every age group of the society. Spurious drugs are expanding rapidly and thus emerging as a menace. Standard quality obligations are related to number or factors. Hence, the Government should take proper preventive measures to control the spread of Spurious Drugs or drugs which are not of standard quality whereas both the sellers and the manufacturers should remain cautious regarding the misbranded and adulterated drugs in the market.

REFERENCES

Art. 21, the Constitution of India.

S. 13,15,16,17(A)(B),19,27 & 36AC Drugs and Cosmetics Act, 1940.

Drugs and Cosmetics (Amendment) Bill, 2007

S.9(a),11,134(b) & 135, The Trade Marks Act, 1999.

S. 274, The Indian Penal Code, 1860.

Brahmaji V/s state of U.P. & others, (1954) AIR 10.

Allergen Inc. v. Sun Pharmaceuticals Industries Ltd. (2006) 2CHN179.

Novartis AG v. Union of India. (2013) 13SCR148.

Ministry of Health and Family Welfare, Government of India, Mashelkar Committee report 2003, available at https://thehealthmaster.com/wp-content/uploads/2019/10/Mashelkar-Committe-report-2003-1.pdf, last seen on 10/1/2023.

[1] Art. 21, the Constitution of India.

[2] Ministry of Health and Family Welfare, Government of India, Mashelkar Committee report 2003, available at https://thehealthmaster.com/wp-content/uploads/2019/10/Mashelkar-Committe-report-2003-1.pdf, last seen on 10/1/2023.