This article has been written by Anindita Deb, a student from Symbiosis Law School, NOIDA. In this article, the author attempts to explain provisions of the Drugs and Cosmetics Act. 1940, its distinctive features, and its lacunae. 

This article has been published by Sneha Mahawar.

Table of Contents

Introduction 

India is pacing toward technological developments in every field, medical science being one of them. Since the COVID times, India has shown great innovation and participation in every step of the process of protection of health and advancement towards safety measures. But all these processes need to be backed up by the law, and the law needs to constantly evolve in order to accommodate all the new changes we are witnessing in the field of medical science. 

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The Drugs and Cosmetics Act, 1940 (DCA), is one such law that governs the manufacture, import, and distribution of medicines in the country. It was followed by the Drug and Cosmetics Rules, 1945, which categorised the drugs into schedules and provided regulations for the sale, storage, and prescription of each category. The article seeks to discuss its provisions, as set out in 1940, and how the legislation has been enhanced in the past two decades and what new rules and legal provisions have been introduced into the Act. 

Objectives of the Drugs and Cosmetics Act

The Drugs and Cosmetics Act aims to hold medical technology and pharmaceutical companies liable for negligence and sub-standard services provided by them. A major objective of enacting this legislation was to prevent adulteration in medicines. Some other objectives have also been discussed below:

  1. Regulation of the sale, import, and distribution of drugs and cosmetics by means of licensing.
  2. Ensuring that only qualified individuals are involved in the import, distribution, and sale of drugs and cosmetics. 
  3. Preventing substandard drug quality, presumably in order to maintain high medical treatment standards.
  4. Regulation of the production and sale of Ayurvedic, Siddha, and Unani drugs.
  5. To form a Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for allopathic and allied drugs, as well as cosmetics.

Relevant definitions in the Drugs and Cosmetics Act

In order to obtain a better understanding of the provisions of the Act, we need to first familiarise ourselves with certain terms that have been defined within it. Some of the terms used throughout the Act have been defined hereunder. 

Drug 

Under the Act, ‘drug’ has been defined in Section 3 by categorising the term to include 4 categories, which are as follows:

  1. All the medicines which are meant for internal or external use on humans or animals, and the “substances used for or in the diagnosis, treatment, mitigation or prevention of any disease in human beings or animals.” This also includes preparations that are applied to the human body as repellents for insects like mosquitoes. 
  2. Substances other than food that may affect the structure or function of the human body or that are used to destroy insects or vermin that cause disease in humans or animals, as the Central Government specifies through a notification in the Official Gazette from time to time.
  3. It also includes the substances that are used as components of a drug, including empty gelatin capsules. 
  4. The devices that are used internally or externally on the human body or on animals for the purpose of diagnosing, treating, mitigating, or preventing any disease or disorder, as may be specified by the central government in the Official Gazette from time to time after consulting the Drugs Technical Advisory Board (DTAB). 

Cosmetic 

It has also been defined under Section 3 and refers to any item that is “intended to be sprayed, poured, rubbed, or sprinkled on, introduced into, or applied” to the human body or any part of it for cleansing, beautifying, promoting attractiveness, or altering appearance. It also includes any items intended for use as a cosmetic component.

Misbranded drug 

A drug will be considered a misbranded drug under the following 3 conditions:

  1. If the drug has not been labelled in the manner as it has been prescribed. 
  2. If it is coloured, coated, powdered, or polished in order to conceal any damage, or if it is made as such, it appears to be of better or greater therapeutic value than it actually is.
  3. If the label or container coming with the drug bears any statement, design, or device making a false claim about the drug or giving any misleading information. 

Ayurvedic, Siddha or Unani drugs 

This term, defined under Section 3(a) encompasses all medicines which are used for internal and external purposes in diagnosis, treatment, prevention or mitigation of disorder or disease in humans or animals. These medicines have to be manufactured exclusively in accordance with the formulae laid down in the authoritative texts of Ayurvedic, Siddha, and Unani Tibbi Systems of Medicines provided under the First Schedule to the DCA. 

Patent or proprietary medicine 

The meaning of this term, as defined under Section 3(h), can be derived as follows:

  1. In relation to the Ayurvedic, Siddha, or Unani systems of medicine, “all formulations containing only the ingredients mentioned in the formulae described in the authoritative books of the Ayurvedic, Siddha, or Unani systems of medicine specified in the First Schedule to the Act,” but excluding the medicine in which parenteral administration is used.
  2. In relation to any other system of medicine, including allopathy, a drug is introduced in a form “ready for internal or external administration” of humans or animals that is not currently included within the editions of the Indian Pharmacopoeia or any other Pharmacopoeia.

Adulterated drug 

According to Section 9A, a drug will be treated as adulterated if it falls into one of the below categories:

  1. Whole or part of it consists of “any filthy, putrid, or decomposed substance”, or 
  2. It has been “prepared, packed, or stored under poor sanitary conditions” due to which it may have been exposed to contamination and hence rendered injurious to health, or 
  3. The whole or part of the composition of the container of the drug was “of any poisonous substance which may render the contents injurious to health,” or 
  4. The drug contains a colour that is not prescribed, or 
  5. The drug contains a harmful or toxic substance that renders it injurious to health, or 
  6. It is mixed with a substance that may reduce the drug’s quality or strength. 

Manufacture in relation to drugs or cosmetics 

Although the term ‘manufacture’ has not been explicitly mentioned in the Act, it refers to any process that is fully or partially used for “making, altering, ornamenting, finishing, packing, labelling, breaking up, or otherwise treating or adopting any drug/cosmetic with a view to its distribution or sale, but does not include the compounding or dispensing of any drug or cosmetic in the ordinary course of retail business.”

Spurious drug

As per Section 17B of the Act, a drug will be treated as spurious under the following situations:

  1. If the drug has been imported under a name that belongs to another drug, or 
  2. If it is an imitation or substitute for another drug or it has a resemblance with some other drug in a way that it will likely deceive or happens to bear on itself or its label the name of another drug, or 
  3. If the name of a person or business claiming to be the drug’s producer appears on the label or container but that person or business is fictional or nonexistent, or
  4. If the drug has been substituted in whole or in part by another drug substance, or 
  5. If it claims to be the product of a manufacturer or company by which it isn’t actually produced. 

Misbranded cosmetic 

A cosmetic will be deemed misbranded, according to Section 17C, if it falls under one of the following categories:

  1. When it contains an unprescribed colour, or 
  2. When the cosmetic is not labelled as it was prescribed to be, or 
  3. When the label or container of the cosmetic or anything that accompanies the cosmetic happens to bear any statement that is false or misleading in nature. 

Spurious cosmetic 

According to Section 17D, a cosmetic will be termed a spurious cosmetic:

  1. If it has been imported under a name belonging to some other cosmetic, or 
  2. If the cosmetic is an imitation of or a substitute for another cosmetic, or happens to resemble another cosmetic in a “manner likely to deceive”, or bears on it or on its label or container the name of some other cosmetic, or 
  3. If the label or container of the cosmetic bears the name of any fictitious person or company claiming to be the manufacturer of the cosmetic, or 
  4. If the cosmetic claims to be the product of a manufacturer who hasn’t really produced the cosmetic. 

Salient features of the Drugs and Cosmetics Act

The Act has made a significant effort toward regulating the pharmaceutical industry in India and hence ensuring the protection of the health and safety of the public. Some of the salient features of the Act can be summed up as follows:

  1. The maximum penalty is life imprisonment and a fine of Rs. 10 lakhs or three times the confiscated goods’ value, whichever is greater.
  2. Other gazette officers, in addition to officers from the Drug Controller’s Office, are authorised to initiate prosecution under the Act; some of the offences are cognizable and non-bailable;
  3. Specialised courts for the trial of offences covered by the Act;
  4. Provision for the aggregation of minor offences.

Wings under the Drugs and Cosmetics Act, 1940 

The Drugs and Cosmetics Act established 3 wings with proper authorities to ensure proper regulation and administration of the Indian pharmaceutical industry. These wings are:

Advisory wing 

This wing consists of two bodies.:

  1. Drugs Technical Advisory Board (DTAB) 
  2. Drugs Consultative Committee (DCC) 

Analytical wing 

This wing consists of the following bodies and individuals 

  1. Central Drug Laboratory 
  2. Government analysts 
  3. Drug Testing Laboratories for the states 

Administrative wing 

The following individuals are responsible for the administration of drugs and cosmetics regulations:

  1. Drugs Controller General of lndia
  2. Drugs Control and Licensing Authorities of States
  3. Drug Inspectors of central and state governments

The functions and features of the significant authorities have been discussed in the following sections of the article. 

Drugs Technical Advisory Board (DTAB)

It is a statutory board established by the Central Government under the provisions of this Act to advise the Central Government and State Governments on all technical matters pertaining to the Act, as well as to establish guidelines for types of formulations as and when requested by the Central Government. It is a technical advisory body composed of members who are ex-officio, nominated, and elected. The DTAB has a total of 18 members who represent various aspects of the pharmacy and medical professions in the country. The Chairman of the DTAB is the Director General of Medical and Health Services, Government of India, and the Member Secretary is the Drugs Controller General of India. The DTAB’s headquarters are located at the Ministry of Health and Family Welfare, Government of India, Nirman Bhavan, New Delhi.

Composition of DTAB

The DTAB comprises ex-officio, nominated, and elected members. The following are the members under each head:

Ex-officio members 

There are 8 ex-officio members, namely:

  1. “Director General of Medical and Health Services, Government of India (Chairman)
  2. Drugs-Controller General of India (Member Secretary) 
  3. Director, Central Drug Research Institute (CDRI), Lucknow, U.P. 
  4. Director, Central Drug Laboratory (CDL), Kolkata 
  5. Director, Indian Veterinary Research Institute (IVRI), Izzatnagar, U.P. 
  6. Director, Central Research Institute (CRI), Kasauli, H.P. 
  7. President, Pharmacy Council of India (PCI)
  8. President, Medical Council of India (MCI)”

Elected members 

There are five positions where members have to be elected:

  1. One professor in pharmaceutics or pharmaceutical chemistry or pharmacognosy is elected by the Executive Committee of the Pharmacy Council of India (PCI) from any university or affiliated pharmacy college.
  2. One professor in medicine or therapeutics in any of the government or affiliated medical colleges is elected by the Executive Committee of the Medical Executive Committee of Medical Council of India. 
  3. One professor in pharmacology and toxicology is to be elected by the governing body of the Indian Council of Medical Research (ICMR).   
  4. One member is to be elected by the Central Council of the Indian Pharmaceutical Association (IPA). 
  5. One member is to be elected by the Indian Medical Association (IMA).

Nominated members 

The remaining 5 members will be nominated by different bodies. They are:

  1. Two members will be nominated by the central government who are in charge of the Drugs Control Department of the state or union territory.
  2. Two government analysts will be nominated by the central government anywhere from the country. 
  3. One industrialist representing the pharmaceutical industry is to be nominated by the central government. 

Term of office 

The term of office for elected and nominated members is three years. Ex-officio members hold office so long as they are in that specific position. Even if they are not members of the DTAB, they can form sub-committees and co-opt member experts for specific assignments. The DTAB makes policy decisions on technical aspects of the Drugs and Cosmetics Act and Rules and forwards its recommendations to the Ministry of Health and Family Welfare for approval. DTAB meets twice a year. DTAB can be summoned with one week’s notice for certain urgent matters. The Ministry of Health and Family Welfare may decide on very urgent matters on a priority basis at times. However, such government decisions must be ratified by DTAB within 6 months.

Drugs Consultative Committee (DCC) 

It is the Advisory Body appointed by the central government under Section 7 to advise the central and state governments, as well as the DTAB, on matters pertaining to the uniform implementation of DCA and Rules provisions. The DCC is made up of two representatives nominated by the central government and one representative each from the state government and the union territory. The state government or union territory usually appoints the Director of Drug Control Administration or Drug Controller of State to this Council.

Central Drug Laboratory (CDL)

The Act directed the establishment of a Central Drug Laboratory (CDL) under Section 6 in Kolkata, and it will be headed by a director appointed by the central government. It is the “Statutory Analytical Laboratory for drugs and cosmetics under DCA whose decision with regards to analysis is final in the court of law.” 

Functions of the Central Drug Laboratory

The CDL is responsible for performing various functions, which are:

  1. It analyses drug and cosmetic samples sent by customs collectors and different courts.
  2. As directed by the central government, it advises the central government, state governments, and union territories on drug and cosmetic analysis aspects, and it also undertakes analytical work of a particular nature for samples sent by the central government and state governments.
  3. It may accept samples for analysis in exchange for a fee from private parties, consumer organisations, and so on.
  4. It is involved in research for the development of newer drug and cosmetic analysis techniques.

Powers of the Director of the Central Drug Laboratory

In order to carry out an effective analysis of the items, the director of the concerned laboratory is vested with the powers of the Director of the CDL as per the Act. The following are the powers:

“1. Director, Central Research Institute (CRI), Kasauli, H.P: for biological preparations such as vaccines, sera, toxins, toxoids, etc., and also bacteriophages, surgical sutures, and ligatures.

2. Director, Indian Venterinary Research Institute (IVRI), Izzatnagar, U.P: for all biological products and other veterinary products meant for animals.

3. Director, Central Indian Pharmacopoeia Laboratory (CIPL), Ghaziabad, U.P: for all homeopathic medicines and condoms.

4. Director, National Institute of Communicable Diseases: Oral Polio Vaccine”

The sample for analysis must be sent under sealed cover via registered mail to the Director of the relevant laboratory. A memorandum filled out by the person posting the sample for analysis in accordance with the procedure should be accompanied separately on the same registered post. A separate copy of this memorandum with the impression of the seal must be sent to the Director via registered mail. The officer delegated on behalf of the Director or the Director himself receives the registered post of sample and memorandum. The impression of the seal in both cases is compared, and its authenticity is confirmed before the seal is opened. The sample must be kept in the custody of the Director or an officer designated by him until the analysis is completed and then for a period of one year. Following the completion of the analysis, the protocol used for the analysis, analytical results, and other pertinent information are sent to the appropriate party via registered mail. Priority for analysis is determined by the importance of the matter. The analysis decision made by CDL is final and cannot be challenged in court.

Drug inspectors 

Drug inspectors are appointed under Section 3(e) by both the state and federal governments for specific areas or categories of activity. A separate set of inspectors could be assigned to the manufacturing of drug formulations. Drug Inspectors work for the Drug Controlling Authority of the state or central government, depending on the circumstances. An inspector has been tasked with ensuring that the Drugs and Cosmetics Act is strictly enforced in his or her jurisdiction.

Qualifications necessary for the position of drug inspector 

In order to hold the position of drug inspector, one must meet the following criteria:

  • The individual should not have a direct or indirect financial interest in any of the activities related to drug import and export, manufacturing, sale, or distribution.
  • A graduate in pharmacy, pharmaceutical sciences, or medicine with a specialty in clinical pharmacology or microbiology from an Indian university is eligible for the position of Inspector.
  • For the purpose of “Schedules C and C (1) drugs”, 

(i) a drug inspector with at least 18 months of experience manufacturing at least one substance specified in Schedules C and C(1) or 

(ii) a drug inspector with at least 3 years of experience inspecting firms manufacturing Schedules C and C(1) drugs or 

(iii) a drug inspector with at least 18 months of experience testing at least one of the substances in Schedules C and C (1) in a laboratory approved for the purpose.

However, these qualifications may not be needed for those who were appointed as an inspector on or before October 18, 1993. Every drug inspector will be deemed to be a public servant as per the definition provided under Section 21 of the Indian Penal Code, 1860. 

Duties of inspectors of premises licensed for sale 

Subject to instructions issued by the controlling authority, an inspector authorised to inspect premises licensed for the sale of drugs has the following duties under Section 51 of the Drugs and Cosmetics Rules of 1945:

  • To inspect all establishments for sale at least once a year.
  • To ensure that licensing conditions are being followed.
  • To obtain and send the drug for testing or analysis if he has reason to suspect that the drug is being sold or stocked in violation of the Act or Rules.
  • To conduct a worded investigation into the complaint.
  • To keep a record of inspections.
  • To conduct the necessary research.
  • To initiate prosecutions for violations of the Act and Rules.
  • When authorised by the State Government, detain imported packages containing drugs, the import of which is prohibited.

Duties of inspectors specially authorised to inspect the manufacture of drugs or cosmetics

The duties to be performed by an inspector are mentioned below. These duties are subject to the instructions issued by the Controlling Authority. 

  • To inspect, at least once a year, all premises licenced for the manufacture of drugs or cosmetics. 
  • To ensure that licence conditions are met.
  • To inspect the plant, manufacturing process and standardisation, storage, technical qualifications, and other details for Schedules C and C (1) drugs.
  • To submit a thorough inspection report to the Controlling Authority.
  • To collect samples for testing or analysis in accordance with the rules.

The inspector is restricted from disclosing any information that he acquires except for official purposes or when the law requires him to do so. He also has the authority to seize records or to prevent the manufacturer from selling the drugs for a period of 20 days if he has reason to believe that they are violating provisions of the Drugs and Cosmetics Act. If needed, he may take xerox copies of the seized documents signed by the owner of the documents. 

A drug inspector is required to conduct a routine inspection of a shop or manufacturing unit within his jurisdiction at least once a year. In general, the inspection should be performed at a reasonable time, preferably during working hours. However, if he or she has reasonable grounds to believe that a violation of the DCA is happening, he or she may raid the premises and seize the documents, records, or medicines, as the case may be.

The sample taken from the drug store should be divided into four parts. The seizure of medicine should be done according to the provisions of the Code of Criminal Procedure, 1973, and in the presence of witnesses. The samples must be sealed, and the drug store owner’s seal should be permitted. In the case of injectables, four different ampoules from the same batch are confiscated. The drug inspector pays the drug store owner the fair price of the seized material, or if the owner refuses to accept money, the receipt is prepared separately and the form is filled out. Any seizure or raid must be immediately reported to the Judicial Magistrate of that area. One of the four samples confiscated is kept by the inspector; one is sent to a government analyst; one is returned to the drug store owner; and the fourth is sent to the manufacturer.

An inspector shall send the sample to the government analyst by registered mail or hand in a sealed packet enclosed with a memorandum on Form 18 in an outer cover addressed to the government analyst. A copy of the memorandum and a specimen impression of the seal are sent separately by registered mail to the government analyst. 

In the event of a raid or seizure of medicine at a manufacturing facility, three seized samples are prepared using the same procedure. The Inspector keeps one sample to present in court. The second sample is given to the manufacturer, and the third sample is sent to the government analyst for analysis.

Following receipt of the analysis report, appropriate action is taken. Regular sales are permitted if the report is satisfactory. If it is not satisfactory, legal action will be taken.

Any physical assault or threat made in writing or over the phone to an inspector while he is performing his duties is considered an offence punishable by imprisonment for up to three years, a fine, or both.

Government analyst 

Government analysts are appointed under Section 3(c) by the central government and state governments to test or analyse drugs and cosmetics. They work in Central Drugs Laboratories and the state and Union Territory’s drug testing laboratories.

Duties of a government analyst 

A government analyst has to perform the following duties:

  • To analyse samples sent by the Inspector, Custom Officer, or other person in accordance with the provisions of Chapter IV of the Act and to prepare a detailed analysis report in triplicate. The entire protocol of the analysis test should be provided. The report should be sent in a sealed envelope to the Customs Department or the Drug Inspector, depending on the situation.
  • Send reports to the government about work done, research done, publications, if any, and keeping drug and pharmaceutical information up to date.

Before beginning analysis, the government analyst should verify the seal and ensure proper custody of the sample sent for analysis. The analytical report should be submitted in triplicate to the inspector or the appropriate person on Form 13. Form 14-A is used for a purchaser’s request for testing or analysis, and Form 14-B is used for the analysis report.

Licensing authority 

This authority is concerned with the issuance of licences for the sale and import of drugs and cosmetics within a particular jurisdiction. Each member of such an authority must be a graduate in pharmacy or pharmaceutical chemistry or in medicine with a specialisation in clinical pharmacology or microbiology. They also must have five years of experience in the manufacturing or testing of drugs.

The duties to be performed by the licensing authority are as follows:

  • To inspect all drug-selling establishments within the area assigned to him.
  • To ensure that the licence conditions are followed.
  • To obtain and, if necessary, send imported packages for testing or analysis.
  • To look into any complaints.
  • To keep a record of all inspections performed and actions taken in the performance of his duties.
  • To conduct such inquiries and inspections as may be necessary to detect drug sales in violation of the Act.

Regulating the import of drugs 

In order to regulate the import of drugs, certain conditions must be met for all types of drugs. The following sections deal with the conditions for each type. 

Import of drugs for personal use 

  1. If the drugs are a part of the passenger’s luggage, up to 100 doses of the drug may be imported without any permit. 
  2. If the number of doses exceeds 100, a licence has to be issued for import,  the application for which can be filled out on Forms 12-A and 12-B. 
  3. The drugs must be for bona fide personal use. 
  4. If the custom collector directs, the drugs must be declared to them. 

Import of drugs for examination, test, or analysis 

  1. In order to import drugs for the purpose of examination, test, or analysis, license is needed under Form-11.
  2. The imported drugs must be used only for the purpose stated and at the specific place mentioned in the licence.
  3. The record with respect to quantities, the name of the manufacturer, and the date of import must accompany the drugs. 
  4. An inspector must be allowed to inspect the premises and check records. 

Import of drugs without licence 

Some drugs are eligible to be imported without a licence. These are:

  1. Those substances which are not used for medicinal purposes. 
  2. Drugs under Schedule C, which are required for manufacturing purposes.
  3. Substances like powdered milk and cereal oats, which are both drugs and foods.
  4. Pre-digested foods. 

Prohibition on the import of certain drugs 

A number of drugs are completely prohibited from being imported. Given below is a list of the same:

  1. Substandard drugs or cosmetics.
  2. Misbranded, counterfeit, or adulterated drugs or cosmetics.
  3. Importing  those drugs or cosmetics which require a licence.
  4. Any patent or proprietary medicine that does not have a true formula or a list of active ingredients and their amounts.
  5. Any drug or formulation which claims to prevent or cure diseases mentioned in Schedule J.
  6. Any drug or cosmetic whose manufacture, sale, or distribution is illegal in the country of origin.
  7. Any drug that is not packed or labelled in accordance with the provisions of the Act.
  8. Any cosmetic that contains an ingredient that may make it unsafe or harmful.
  9. Any drug or cosmetic whose import is prohibited by the Act.

Penalties under the Drugs and Cosmetics Act, 1940 

The offences and penalties under the Act can be summed up as follows:

  • Any adulterated or counterfeit drug or cosmetic imported into the nation in contravention of the Act’s requirements is punishable by up to three years in prison and a fine of up to 5,000 rupees.
  • Any medicine or cosmetic other than the one mentioned in the above point that is illegally imported is subject to a six-month prison sentence, a fine of Rs. 500.00, or both.
  • Any medication or cosmetic imported in violation of the terms of a notification issued under Section 10A is punished by up to three years in prison or a fine of Rs. 5000.00.

Drugs and Cosmetics Rules

In order to supplement the Drugs and Cosmetics Act, 1940, subsequent sets of rules have also been introduced to accommodate the changes in the pharmaceutical industry due to technological advancements and other changes in the field. 

Drugs and Cosmetics Rules, 1945

The Drugs and Cosmetics Rules, 1945 are Indian government regulations enacted in order to complement the Drugs and Cosmetics Act, 1940. These rules categorise medicines according to timetables and provide storage, sale, display, and prescription guidelines for each timetable.

The Drugs and Cosmetics Rules of 1945 include provisions for categorising drugs into schedules, as well as guidelines for storing, selling, displaying, and prescribing drugs within each schedule. Rule 67G specifies the terms of licences. Rule 97 specifies the labelling requirements. It also established that the Drugs Technical Advisory Board is the highest decision-making authority when it comes to drug technical specifications.

The New Drugs and Clinical Trial Rules, 2019 

The Government of India published the New Drugs and Clinical Trials Rules 2019 (New Rules) in the Gazette of India on March 19, 2019.  The new rules are designed with the intention of promoting clinical research in the country and will alter the regulatory landscape for new drug authorization and clinical trial conduct in the country. The new regulations include provisions for encouraging clinical research as well as more complex topics like orphan drugs, post-trial access, and pre and post-submission meetings. The new rules are organised into 13 Chapters (with 107 Rules) and eight Schedules. Except for stem cell and cell-based products and veterinary vaccines, the new rules will apply to all biological products (human vaccines and r-DNA products).

Case laws 

Sri G Ramesh Reddy v. The State By Drugs Inspector (2013) 

This case relates to falsified medical products and Sections 18, 27, and 34 of the Act. 

Facts 

According to the accusations made by the petitioner, the respondent took samples of Pioneer Pharma’s Kranzox tablets and two other medications for testing and analysis by drawing from M/s. D.P. Pharma. The samples that were taken and the medications that were seized were sent for analysis, and the results showed that the quality of the drugs was not up to par. Following an investigation, it was discovered that M/s. B.L. Pharma Ltd. was the manufacturer of the medications and the respondent was its director. 

Judgment 

The judge, in this case, reaffirmed rulings in earlier cases of a similar kind, holding that a director may not be involved in a company’s daily operations. As a result, the director cannot be immediately implicated simply because of his position unless there is prima facie evidence that the director performed a specific act that led to the commission of the crime.

The State of Karnataka v. S.B. Shivashankar (2018) 

This case relates to an appeal for adequate punishment under Section 27 of the Drugs and Cosmetics Act. Let’s check out more details about the case.

Facts 

The respondent, in this case, was accused of selling drugs without a prescription. He carried out the sale of scheduled drugs without the presence of a registered pharmacist and also did not issue any sale bill for the same. He was convicted under Sections 18(a)(vi) of the Drugs and Cosmetics Act, 1940 along with Rule 65(2) and Rule 65(3)(1) of the Drugs and Cosmetics Rules, 1945 which is punishable under Section 27(d) of the Act of 1940. However, the accused only has to spend a day in jail till the rising of the court, and he was penalised with a fine of Rs. 10,000 and 3 months’ imprisonment in case he fails to pay this fine. The petitioners appealed to the appellate court under Section 374 of the Code of Criminal Procedure that this punishment is inadequate since the fine prescribed under Section 27(d) cannot be less than Rs. 20,000. The same was rejected. Hence they filed an appeal before the High Court of Karnataka praying for increased punishment as the punishment granted to the accused will lead to miscarriage of justice. 

Judgment 

The Karnataka High Court dismissed the appeal since the trial court had accepted the application of “plea bargaining” and the penalty on the accused was the result of the bargaining done by the petitioners and they had accepted the same. Hence, there was no ground to call for interference by the High Court on the same. 

The Drugs, Medical Devices and Cosmetics Bill, 2022 : the most recent step towards stringent regulation 

A draft Bill titled “The Drugs, Medical Devices and Cosmetics Bill, 2022” was placed on the table by the Ministry of Health and Family Welfare in early July and it invited public consultation till August. The Bill seeks to supplant the Act of 1940 since new factors now need to be introduced in the legislation for the pharmaceutical and medical fields in India. The proposed Bill’s primary objective is to ensure and offer comprehensive legislation to control that medical item marketed in a country are secure, efficient, and meet predetermined criteria of quality. One of the main purposes for introducing this Bill is to regulate medical devices and manufacturers of medical devices, since the old Act does not accommodate the same aspect. Some of the salient features of this Bill can be summed up as under:

  1. The Bill has introduced a new definition of medical devices and the setting up of a regulatory body.
  2. It has specifically broadened the regulations on the import of medical devices. 
  3. Another important aspect this Bill has inculcated is the regulation of Ayush drugs. 
  4. The Bill also introduces provisions for clinical trials for drug testing. 
  5. A highlight of this Bill is the regulation of online pharmacies since there are currently no specific and explicit rules relating to the sale for pharmaceutical products online. 
  6. The penalties for certain offences have also been maximised to create a deterrent effect. 

Conclusion 

In recent years, a lot of new players have emerged in the pharmaceutical market looking to make a profit in the health industry. Hence, it is important to ensure that they do not capitalise by putting the health of the people at risk. The Drugs and Cosmetics Act of 1940 is comprehensive legislation to ensure that there is efficient regulation of the pharmaceutical industry in India. It has sufficiently evolved and developed to accommodate changes with changing times, and the Act has negligible lacunae within itself. The definitions within the Act are very conclusive and have left no scope for further interpretation, which is good considering that any space left for abuse of the law in this respect could seriously harm the health and safety of the public. Hence, it is important to ensure that regulations under the Act are being complied with in the interest of public safety. The step taken by the government of formulating new legislation that will regulate medical devices as well is also highly applaudable. 

Frequently Asked Questions (FAQs) 

What kinds of cosmetics are prohibited from being manufactured?

There are certain kinds of cosmetics that are prohibited from being sold. These include:

  1. Misbranded or spurious cosmetics which are of substandard quality. 
  2. Cosmetics that contain hexachlorophene or mercury compounds.
  3. Cosmetics that contain colour with more than 2 ppm of arsenic, 20 ppm of lead, or 100 ppm of heavy metals. 

What are the classes of drugs that are prohibited from being sold?

The classes of drugs prohibited from sale are:

  • Misbranded drugs 
  • Spurious drugs 
  • Adulterated drugs that are not up to the quality standard 
  • Patent or proprietary drugs which have not disclosed the formula 
  • Schedule J drugs
  • Drugs that have expired
  • Drugs that are used for government schemes
  • Samples made for physicians

What does the Third Schedule of the Act deal with?

The Third Schedule categorises the drugs for which the Licensing Authority can issue a licence and permission.  

References 

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