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Adulteration of Drugs

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Adulteration of Drugs

Nowadays, drugs have become an inevitable part of our lives as we need them to restore or preserve our health.  It is, thus, imperative to ensure that the consumers use quality drugs at a reasonable price. The main reason behind the implementation of the drug laws was to curb the menaces and exploitation of consumers like adulteration of drugs, misbranded drugs, spurious drugs.  Further, in India, the authorities like the National Pharmaceutical Pricing Authority; Drugs Controller/ FDA of the respective state; and the Drugs Inspector of the respective District, are responsible for the implementation of Drug Laws.

What is an Adulterated Drug?

As per Section 3(b) of the Drugs and Cosmetics Act, 1940, the word “drug” includes the following:

  • All the medicines for external or internal use of human being or animals and all the substances meant to be used for or in the treatment, diagnosis, prevention, or mitigation of any disorder or disease in human beings or animals, together with ointments applied on the human body for repelling insects and bugs like mosquitos, wasp.
  • All the Substances which are expected to affect the functioning of the human body or are used for the destruction of bugs which causes disease in animals or human beings, as may be prescribed by the Central Government by notification in the Official Gazette. 
  • All the substances intended to be used as components of a drug including empty gelatine capsules; and
  • Such devices which are intended for external or internal use in the treatment, diagnosis, prevention or mitigation of disease or disorder in animals or human beings, as may be prescribed by the Central Government by notification in the Official Gazette after discussion with the board.

Hence, the definition of the term “drug” is a comprehensive definition exclusive of only substances and medicines, which are exclusively prepared or used for the Ayurvedic or Unani system. The same was reiterated by the Hon’ble Supreme Court in the case, “Ishwar Singh Bindra v. State of UP.”

Who can file a Complaint against the Adulteration of Drugs?

The following listed are the ones who are eligible to file a complaint against the Adulteration of Drugs:

  • Consumer;
  • Any Registered Voluntary Organization;
  • Two or more consumer having mutual interest.

What is the Procedure for Filing a Complaint against the Adulteration of Drugs?

A consumer can sue the seller, manufacturer, or distributor of cosmetics or drugs under section 274 or 275 of the Indian Penal Code.  For the offence of Adulteration of Drugs or Sale of Adulterated Drugs. The same can be done by filing an FIR (First Information Report) against them.

The aggrieved person can also file a complaint in the “Consumer Dispute Redressal Forum” at District, State or National level. The steps involved in the procedure for filing a complaint against the adulteration of drugs are as follows:

  • Step 1: The complaint can easily be made on a simple paper. Hence, having a stamp paper is not at all necessary for it. Further, one can also file a complaint concerning Adulteration of Drug on a consumer portal:consumerhelpline.gov.in.
  • Step 2. The complaint about the Adulteration of Drugs should be drafted in such a way that it states all the necessary facts and also establishes the cause of action. The following listed are the particulars that need to be specified in the complaint by the consumer:
    • Complainant’s name and complete details like address, contact number, and E-mail ID;
    • Full Details of the Opposite Party;
    • Date and Time of the purchase of drugs or the services availed along with the amount paid for them;
    • Particulars of the dispute, like adulterated drugs or inferior quality of drugs etc.
    • Particulars and Details of the relief sought by the Complainant in the complaint;
    • Details of the Drugs or medicines purchased together with the numbers;
    • Copies of all the required documents can be annexed, which supports the contention of the aggrieved and are also necessary to establish the cause of action. These documents include a copy of bills of drugs/ medicines/ cosmetics bought, a copy of the complaint made to seller demanding to compensate for the loss incurred;
    • The Complaint must mandatorily be signed either by the complainant or his authorized agent.
  • Step 3: The compensation claimed for the adulteration of drugs should be mentioned in the complaint, and together with it, the aggrieved person can also demand damages, refunds, litigation expenditure, etc. However, these amounts must be detailed under different heads and as per the pecuniary jurisdiction of the respective consumer forums.
  • Step 4: The statement of jurisdiction should also be mentioned in the complaint as to how the particular case falls under the ambit/ jurisdiction of the consumer forum.
  • Step 5: A affidavit of verification must also be affixed with the complaint describing that all the facts stated and claims made in the respective complaint are true and correct.
  • Step 6: At the end of the complaint, the sign should be put. The aggrieved person may argue his case on his own or by way of his authorized representative. Further, the complaint filed with the District Forum or the State Commission requires to be filed in a set of three. However, when a complaint is registered with the National Commission, it should be filed in a set of four together with the additional sets for each opposite party.
  • Step 7: It shall be relevant to take into consideration that the complaint is required to be filed with within a period of two years, starting from the date on which the “Cause of Action” arose. If in case there is a delay in filing the complaint, the complainant needs to give sufficient reasons to the forum, so it may permit the complainant to file his complaint.

What is the Time Limit for Disposing of a Complaint of Adulteration of Drugs?

The Consumer Dispute Redressal Forum needs to dispose of a complaint within three months, starting from the date of filing the complaint.

What is the Procedure for Filing an Online Complaint against the Adulteration of Drugs?

The Government of India runs an online, offline as well as a telephonic helpline for redressing consumer grievances.  The following listed are the ways for filling an online complaint against the Adulteration of Drugs:

  • An aggrieved person or a complainant can register his grievance either by means of the NCH (National Consumer Helpline) App, Consumer App or through the UMANG app.
  • The National Consumer Helpline numbers to register or file complaints are 1800-11-14404 and 4000.
  • One can also send a message on 8130009809 to register his complaint.
  • A complainant can also lodge or file his complaint by visiting the official consumer helpline portal consumerhelpline.gov.in. Over there, the complaint system has an option that comprises of all the brands registered with the Department of Consumer Affairs. While filing the complaint, the complainant can also annex all the required and supporting documents with that online complaint. After that, the complaint file can proceed and disposed of by way of the same mechanism and without visiting the Consumer Dispute Redressal Forum.

How much is the Punishment Prescribed under the Indian Penal Code?

The punishment prescribed for the offence related to Adulteration of Drugs are as follows:

  • Section 274: Adulteration of Drugs: Any manufacture who adulterates any drug or medicine, or to make it noxious and harmful, and aiming that it shall be sold, shall be punished with imprisonment for a term which may go up to six months, or with a fine which may extend to Rs 1000, or with both.
  • Section 275: Sale of Adulterated Drugs: Anyone who knowingly sells or offers to sell any adulterated drug or medicine shall be punished with imprisonment for a term which may go up to six months, or with a fine which may extend to Rs 1000, or with both.

How much is the Punishment Prescribed under the Drugs and Cosmetics Act, 1940?

Under the Drugs and Cosmetics Act, 1940, the punishment of imprisonment for the offenses ranges from one year to five years. Moreover, the punishment may extend further to life imprisonment under section 27(a) of the Drugs and Cosmetics Act, 1940, where the offence is likely to cause death or any bodily injury as prescribed in section 320 of the Indian Penal Code, 1860.

Frequently Asked Questions

  • 1. Can an individual get the test done in case of doubt concerning the nature of a Cosmetic or Drug?

    Any buyer of drug or cosmetic, or any other recognized consumer association, whether such individual is a part of that association or not, shall, on the filing of the application in the prescribed manner, along with the payment of the prescribed fee, be qualified to submit any cosmetic or drug purchased by him for analysis or test to a Government Analyst.

  • 2. If in case, a retailer sells medicines by breaking the seal, what is the maximum price can he charge?

    If in case, a retailer sells unpacked medicines (in loose quantity) the price of such drug must not exceed a pro-rata amount of the price mentioned on the label of the container.

  • 3. What is an MRP? Can medicine be sold at a price less than its Maximum Retail Price?

    The MRP (Maximum Retail Price) printed on the label is the maximum amount payable for that medicine. However, a drug can be sold at a price lower than the MRP.

  • 4. Who are the National Level, State Level and District Level Authorities that are in charge of the implementation of fixed prices?

    a) The National Pharmaceutical Pricing Authority;
    b) The Drugs Controller/ FDA of the respective state; and
    c) The Drugs Inspector of the respective District;
    The authorities mentioned above are the implementation authorities at National/ State/ and District Levels.

  • 5. Will Lawyerinc offer service in my city?

    Yes, Lawyerinc is a 100% online platform rendering all over the nation no matters wherever the individual is residing or conducting his or her business. They just need an internet connection on their mobile or laptop, and we are all set to get your complaint registered.

  • 6. Nikita is the daughter of a manufacturer who owns a big factory/ industry for producing “Paracetamol” tablets. She proposed to her father that the Paracetamol tablets must be made in “Orange” colour to enhance the overall grace of the product. Moreover, it will be pleasing to patients and will increase their sales. In this situation, is she right?

    No, using colours that are not allowed results to the identification of drug as false/ spurious and also attracts legal action.

  • 7. Mr Sharma has recently moved his factory from one area to another. However, he has not made the required changes in the labelling of drugs. This situation deals with which type of drugs?

    This situation deals with spurious drugs, as the valid location of the manufacturer is not accurately specified.

  • 8. Ranbaxy lost its FDA license for manufacturing/ producing drugs in its Indian factories. The reason was that the traces of human hair were noticed in the final tablets supplied by Ranbaxy. This situation deals with which type of drugs?

    This situation deals with the adulterated drug as the final tablets were containing some extraneous matter.

  • 9. Mr Raj is a graduate in B. Pharm, who starts a factory of manufacturing/ producing drugs. His first project was for the supply of “Diclofenac Sodium” tablets for some marketing purposes. However, being new in the industry, he forgot to mention the Schedule H warning on the label of his tablet. In this situation, such a drug will be considered as what?

    The concerned drug in this situation will be recognized as the Misbranded Drugs, due to the deficiencies in its label.

  • 10. What will be the services provided by Lawyerinc?

    a) Free Consultation;
    b) We will get in touch with you through an expert Drug Adulteration Lawyer;
    c) Assistance in Case Filing;
    d) Representation by the well-known advocates in the Court;
    e) Day to day reporting about the status.

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