All about the Act

Analysis of The Drugs and Cosmetic (Amendment) Rules, 2020

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This Blog is written by Illa Mathi Maran from UPES, Dehradun. Edited by Ravikirna Shukre.

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INTRODUCTION:

The act of drugs and cosmetics is the act which was made in 1940, the pre-independent era. The act of drugs and cosmetic’s played a major role in the pharmaceutical department. This act was mostly on a part of check and balance in the area of pharmacy. This act was mostly in the part of manufacturing and distribution of the drugs all over India. The main objective of this act was relied on maintaining the flow of cosmetics in India in a safer way. This act checks this flow by guiding some of the important factors like storage, sale, display, and prescription of each schedule.

The act of drugs and cosmetic’s act or drugs act was passed in 1940. This act was made by the “copra committee”, this committee was made in 1930. Before the pre-era of the act was totally different view in which the drugs which are supplied to the people in India were not with proper warranty or safety measures. The term “drug” defines the verity of substance that was used to rectify the problem of the people.[1] The term “cosmetics” is the kind of product that is used by people to enhance their beauty. The act was amended due to the high diametric situation in the security of selling human using products in the markets. These acts were made under huge demand to help people maintain a sustainable life.

Due to the development in the world, there requires an alternative form of laws in this act, thus this act was mainly questioned in various aspects and it gets re amended 8 times. The main reason for the amendment is to reinforce its loyalty to the current world. The ministry of health and family welfare was recommended an important task to be added to this act, which is to regulate the medical devices which are used by the factory to produce drugs and cosmetics. Then this point was hugely supported and resulted in creating of the “international medical device regulators forum”. Started on February 11. The main function of this forum is to discuss future directions in medical device regulatory harmonization. The “medical devices and diagnostic divisions questioned this forum for ‘making awareness in the public regarding the act and its applications’. For the purpose of awareness among the people and selling drugs and cosmetics in a safer way this act was re-amended by the “ministry of health and family welfare” into the medical devices (amendment) rules 2020.

SIGNIFICANCE OF THIS DEVELOPMENT:

There will be certain purposes and significance for creating an amendment. The medical devices amendment rule 2020 has its main objectives. As we saw that this act maintains the flow of product in the market, it has its significant functions as follows –

• The drug controller general of India mentioned that many of the pharmaceutical companies are procuring drugs that are manufactured by smaller contract manufacturers to ensure that they will to be liable under DCA, this becomes the tactics in the higher companies to pull the lower smaller producers in the liability. The amendment helped as a defensive role in small-scale manufacturing.

• The main purpose of the amendment was to increase the quality of drugs in an effective and good manner. This will help to carve therapist practice of marketing of unapproved or spurious drugs

• This amendment used to avoid the line between big pharmaceutical companies to smaller manufacturers, there will be a review to ensure trapping of market agreement.

• This act making a barrier in making the contract in manufacturing arrangement to prevent itself from being classified in between one.

• These indemnity protections help from re-negotiation to provide markets in back–to–back indemnity in relation to complaints about the requirement under DCA.

These, are some of the significance that sustains the flow of products between industry and people (consumers).

IMPACT:

The result of the formation of the act becomes a major concern in the higher producers /manufacturers. This act is considered as a check-in this case for the companies. If we see this concept in a legal way, the medical instruments should be registered and notified to the government but, if we analyze the current status “only 37 medical devices are notified as drugs”.[2] These 37 medical devices only fully assured by the government to be used in the process of preparing drugs and cosmetics. There are many illegal and unregistered devices were being used by the manufacturers.

This act made a huge impact on the organizational flow of products and the security of the materials used in the preparation process. The changes in the OTC (over–the–counter) medicines were also the reason which the alternative act was made. The main motive of this change was explained by the senior officer of TOI, who stated as “the move is aiming to promote self-care and reducing the cost of treatment without compromising patient’s safety. It will also help us to ensure the presumption only drugs are not misused, while other commonly used medicines which are not toxic are easily available to patients”.[3]

The separate committee was made into the finding of the list of OTC products along with the draft for the amendments in the law. The OTC category was separately made for the analysis of the illegal medicines and their supply. It is made as an important criterion for the medicines to be switched from prescription to OTC. These types of medicines can also be get advertised for making awareness among the people and sale purpose.

PROVISIONS IN THE LEGISLATURE:

In this act of drugs and cosmetics, various changes happened and there is an alternate gazette was made by the government with the suitable changes done. Under this amendment shall voluntarily register for a period of 18^th month from 1^st April 2020 with central licensing authority identifies established by central drug standard control organization, this process was also made compulsory.[4]

• The manufacturer of the medicine requires to upload the information regarding the “online system of medical devices”

• The IOS certificate made a compulsory view on the medicines to the publishing in the market and using products.

• The necessary information should be attached along with the product, and also required to furnish a “free sale certificate” from the country detailed specific rule 19D (2) (II).[5]

The gazette explained the important points to be followed in the sale and using of medical products and also in the preparations of drugs and cosmetics.

CASE LAWS:

There are various crimes accrued related to drugs and cosmetics. This disloyalty was made a serious threat to human life. The famous case which majorly concerned in this drugs and cosmetics is Sri G Ramesh Reddy v. the State by drugs Inspector[6]

Facts:

The allegation made the respondents took sample tabs, manufacture by pioneer pharm, with two drugs for test and analysis by framing from D.P. Parma. The sample is drawn and seized and analysis of the report analysis revealed the drug is not the sanded quality. Thereafter, during the inquiry, it was revealed that the drug was manufactured B.L pharma ltd.

Issues:

The liability of legal persons as per legislation that seeks the guarantee the safety and quantity of medicines.

Judgment:

The judge discusses the requisites level of involvement of the company directors in the crime allegedly by the company. Being the director may not be concerned with day-to-day work in the company.

This case was also made a force for the alter in the laws which are related to drugs and cosmetics. The case is mainly considered while creating and altering the section in this act.

ANALYSIS:

We all know a new law or an amendment will be created only for some special reasons, by the way, this act has its own reasons. In the previous era of independence, the flow of drugs and cosmetics was not that high, so that made less possibility for the occurrence of crime. In this era of the world, we are flourished with products of drugs and cosmetics, so it will lead to the high possibility of cheating people. As we have already seen that the main objective of this act is to “regulate the import, manufacture, distribute and sale drugs & cosmetics through licensing”.

Procedure to be followed (Under the Guidelines of this Act)–

• This act is giving power to the central licensing authority & central drugs standard control organization (CDSCO). All the drug manufacturing companies need to register their equipment through an identified online portal established by CDSCO.

• This registration will be voluntary for the 18^th, after which it will be mandatory for the manufacturing companies.

If we analyze the impact of this act, the decision majorly imposed on the small and marginal players, largely in the low-value high segment of medical industries. The hi-tech diagnostic dominant players will have the least impact. The concern raised the rigidity and non –conformity treated as criminal offenses. The drug inspectors were given the power to act at his discretion.

CONCLUSION:

If we concern about this act the latest amendment brought a greater ambit of dominance in “medical devices” within medical devices rule 2017[7] they brought many regulatory frameworks the assemble the rules in a file. The government strictly regulates the provisions of this rule to emphasize of giving the primary importance to ‘safeguard the people against illegal and unregistered drugs and cosmetics’. The changes which are made in this rule mainly represent the manufacturing companies to invest proper mechanism to all compliances using this act. This act also provides some of the specific procedural compliances by importers of medical devices. This will boost the international market of medical devices in an ‘ease of doing businesses. In the current pandemic situation, the world is witnessing a major shift in its supply chain and manufacturing process.

We can really appreciate the government which implemented this act to maintain the sustainability of the medical flow among the people. At the same time with proper safeguard and conditions in it. If we take a framework made in a short period of time and made a huge impact on the economy, we can definitely quote this act as an idle example. This act is extremely beneficial for the medical industry as well as the economy of the nation.