REMEDIES AVAILABLE UNDER CONSUMER PROTECTION ACT REGARDING DRUGS AND COSMETICS

 

REMEDIES AVAILABLE UNDER CONSUMER PROTECTION ACT REGARDING DRUGS AND COSMETICS

As per official reports and statistics, the pharmaceutical market in India was

worth USD 33 billion in 2017 and it is expected to reach USD 55 billion by

2020. With initiatives like Pharma Vision 2020 which aim at making India

the most attractive destination for development of new drugs, it is clear

that the pharmaceutical sector will only continue to grow in size.

CONSUMER ISSUES

Drugs are consumed for the purposes of medical treatment. Accordingly, it

is necessary that the process of development and approval of drugs for

human consumption should ensure that the drugs are of suitable quality and

do not have any negative effects. Further, the prices of the drugs need to

controlled so everyone has access to healthcare. In this light, the problems

faced by consumers are:

1. Overcharging of drugs.

2. Selling of untested drugs/drugs of poor quality.

3. Overcharging of medical devices.

4. False/misleading information about the drug.

5. Refusal to sell drugs.

6. Shortage or non-availability of drugs.

 

CENTRAL DRUGS STANDARD CONTROL ORGANISATION

The CDSCO is the regulatory body responsible for approval of drugs,

conducting clinical trials, laying down the standards for quality of drugs and

improving accessibility to drugs. For this purpose, the Drugs and Cosmetics

Act, 1940 provides for establishment of the Drugs Technical Advisory Board

for administration of technical matters, Central Drugs Laboratory for testing

of drugs and the Drugs Consultative Committee for uniform implementation

of the act.

In order to give effect to the provisions of the act, there are numerous

legislations and regulatory mechanisms in place:

1. The Drugs and Cosmetics Rules, 1945 lay down the procedures for

sampling, analysis, import, approval, distribution of drugs etc.

2. The Drug Price Control Order, 2013 lays down the method for

calculation of price of drugs and provides for seizure of drugs in

case of non-compliance.

3. The Pharma Jan Samadhan scheme was launched by the Union

Ministry of Chemicals & Fertilizers. It provides an online facility

for consumers to redress grievances about over-pricing, shortage or

unavailability of medicines and refusal to sell etc.

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CASES

Lability of manufacturer

Dinesh B. Patel v. State of Gujarat

Facts: The case arose out of the medicines which where sold by M/s. Denis

Chemical Lab. Ltd., Chhatral, Ta. Kalol, District Gandhinagar, while testing

the some of the medicines in the laboratory the medicines where found to

have containing fungus there for the case was filed before the district and

then an SPl has been filed against the managing director and on behalf of

the company as in the section 34 of the act says that any offence done by the company the whole company and the people relation to the company will be liable to it.

Issue: Whether the manufacturer held liable?

Decision: The Honourable Court said that after further reference of the cases

the court said that “Under the peculiar circumstances of this case and realizing the seriousness of the allegations, we would not take a technical view based on pleadings in the complaint. Mr. Raichura contended that as per the settled law by this Court in complaints under Section 138 of the Negotiable Instruments Act against company and directors also specific averment about the active role of directors in running the company has to be made, failing which the directors cannot be proceeded against. Same logic should apply even in the present case. We cannot agree. Firstly, the language of Section 34(2) of the Act substantially differs from the language of Section 141 of the Negotiable Instruments Act. Secondly, here we are dealing with the offence which has the direct impact on the public health. We, therefore, would choose not to interfere with the order of the High Court. It will be open for the directors to show to the Trial Court that they had nothing to do with the manufacture process and, therefore, they should not be held liable under Section 34(2) of the Act”. With these observations, the appeal stands dismissed.