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  The union health ministry   has published a draft notification vide no. GSR 98 E dt 5.2.2021 on Medical Devices Amendment rules 2021 to involve American Standard Test Method (ASTM) in standards of product for all medical devices to increase the competency of indigenous medical devices internationally. According to the draft rule, all these rules might be called the Medical Devices (Amendment) Rules 2021 . All these rules will come into force on the date when they are finally published in the official gazette. In the medical device rules 2017, in rule 7, in sub-rule 2, after the words, letters, and bracket" the international electro technical commission ," the words, letter, and bracket or "American standard test method " will   be inserted. The following draft of specific rules for amending MDR 2017 is done while exercising the powers given by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act,1940. In consultation with

Customs duty is a type of indirect tax that is imposed on both the exported as well as imported goods and services. The tax that is imposed on imports of goods and services is called import duty and the tax imposed on the export of goods is called an export duty. The Government of India charges these taxes at the time of import and export of goods and services for raising money to protect the home establishments from the rivals from other countries. Lately, the Indian Government has made some alterations in the whole tax system of the nation. GST was introduced which is a new tax collection system that is a location-based tax that implies that the customer is required to pay when they will be using any goods or services. Before this new system, there were multiple taxes like service tax, value-added tax, central excise etc. that were imposed on several goods and services. After GST these multiple taxes have been replaced by one single tax system. Some of the common trading partners

  The shelf life of a cosmetic is the time over which a cosmetic product holds its specified properties provided they are stored in conditions as directed. Or in other terms, it is the period of which the manufacturer has predicted for the product to best suit for using. When there is a change in the quality of the product with time, it is generally a function of the storing temperature, package precautions, composition of the product, humidity, water activity, quality of the ingredient along with the processing conditions. It is the responsibility of the manufacturers to estimate the shelf life for all cosmetic products they have manufactured and it is a crucial part of their task for product safeties. Failing to do so might result in product adulteration and it is also required for cosmetic labelling requirements India. The voluntary shelf life of product guidelines usually varies based on the product and its required use. In general, cosmetic products are formulated and are tested f

In India, the cosmetic industry is gaining immense popularity at a rapid speed. With a rapidly growing industry it is important to make sure the product safety and this is the reason the Ministry of Health and Family Welfare in India has made it mandatory to obtain the registration certificate for cosmetic imports in India . For importing cosmetics in India ●        The manufacturer should have a registered office in India. ●        An authorized agent of the manufacturer or a subsidiary agent of the manufacturer. The cosmetics should be registered with CDSCO under the Ministry of Health and Family Welfare. Submit the filled application form to Central Drug Standards Controller of India in electronic form. It is also required to submit the application form 42 along with the cover letter. It is a receipt in support of the original payment of the registration fees of amount USD 2000. The office of the DCGI will then provide a copy of the cover letter that serves as an ackno

Phenoxyethanol is found in most of the cosmetics we use today. It is one of the most common synthetic preservatives in skincare products and also an important fixative for perfumes. Being a preservative, it helps in preventing the growth of microbes and is mainly found in products where water is present. It is one of the safest alternatives to parabens and is used by companies to mark their products as paraben-free. It is an oily, little sticky liquid having a faint rose-like scent. It is an ethoxylated compound that is formed by a chemical reaction between a known carcinogen ethylene oxide and phenol. The most common cosmetic products in which phenoxyethanol is found are moisturizers, mascaras, sunscreens, eyeshadows, soap, fragrances, conditioners, lip products, and any water-based cosmetic products. A large number of mainstream and boutique cosmetics consist of phenoxyethanol as it is used as a preservative or a stabilizer in place of other ingredients which otherw

The inclusion of heavy metals in cosmetics is an inevitable truth. Cosmetics, either natural or artificial do contain some amount of heavy metals in them. These can be present as manually added ingredients or just contaminants. Nonetheless, the presence of heavy metals cannot be ignored due to their far reaching negative effects on the human metabolism and health. However, the addition of heavy metals is a necessity for some cosmetic products. This in turn requires the regulatory authorities to draft strict and scientifically safe limits for their composition in cosmetics. As a matter of fact, many cosmetics used on a daily basis, such as lipstick, nail colour, eyeliner, etc, contain heavy metals.  What are heavy metals and what is their impact on human health? In layman terms, a heavy metal is a metal with high density. Examples of some common heavy metals are lead, arsenic, mercury, cobalt, cadmium. Heavy metals are generally toxic for the body because they produce free r

As the global pandemic soars up in the number of people infected and affected, the legalities regarding the import of cosmetics has also been seriously affected. In response to the COVID-19, the government of India had to impose a national lockdown to prevent the further spread of this disease. As a result, all formal establishments and most government offices had been shut down completely. The process of cosmetic product registration has not been untouched by these events, and businesses planning on obtaining cosmetic import licenses are now finding it difficult to cope up with certain legal formalities of the process. Especially the submission of notarized documents. To counter this issue and to ensure seamless processing of applications, the Directorate General of Health Services (Cosmetic Division), CDSCO released a notification on 20th of April, 2020.   According to this notification, applicants submitting documents for the import/registration of cosmetics

The demand for cosmetic products has been increasing at a very unprecedented rate in recent times. Which has made the import and export of cosmetics in India as one of the most prevailing businesses. The market is piled up with a variety of cosmetics like skincare products, lip care products, eye care products and other sections. But along with the increasing use of cosmetics in India, concerns are also rising about the presence of various harmful ingredients that might exist in those cosmetics as a part of their formulation. Especially when the consumers have become more aware and like to stay informed about the products they use. This is the major reason that is compelling the government to take some crucial initiatives to make sure that all the products are of good quality and they are free from all sorts of harmful ingredients. Factors like packaging and labelling are among the basic parts of cosmetic regulatory compliance . Labelling of the cosmetic product refers

One of the most trending ingredients used in cosmetics nowadays is the derivatives of cannabis. Their utilization in some of the major cosmetics is increasing with several products marketed as creams, oils, lotions etc. But a large number of people have confusion about cannabis derivatives, their quality and what their legal implications. Cannabis-based products are divided into several categories depending on their purpose of use and they are further classified as cosmetic purposes or for industrial purposes. This also includes hemp oil which is low in Tetrahydrocannabinol or THC and CBD or Cannabidiol along with the CBD enriched oil and Cannabis oils. THC is known to be the psychoactive part of cannabis and CBD is called the non-psychoactive part. Hemp and CBD oil is regulated as a major cosmetic ingredient in most of the countries. Like in Canada and the European Union, the THC levels of industrial Hemp are strictly regulated and it should be less than 0.3%. Similarly, in

Different countries across the world have their own methods and procedures of dealing with cosmetic regulations. While the USA seems to have a liberal approach for manufacturers, Europe and India follow a more tedious  cosmetic regulatory compliance  which is indeed quite justified. These days the world is more connected than ever. The advent of quick transportation, followed by globalization and the invention of the internet has combined countries and their markets into one global village. The cosmetics industry is not untouched by this globalization, and companies are now expanding multinationally to find new markets for their cosmetic products. Cosmetics are not like grain or stone. Their manufacture and sale is densely regulated by authorities in every country. However, with the markets becoming more globalized, the regulations for cosmetics in different countries have often to be compared for global players. For this discussion, we will take into consideration th

Personal care products are indeed cosmetics and hence have to acquire a cosmetic product registration for manufactured products or a  cosmetic import license  for those being imported. As the society leaps forward and becomes more progressive, t. The importance of physical appearance has become an unwavering matter of importance to many. While the importance of good aesthetics was majorly limited to women’s perspectives. Men have also started enjoying an equable sense of comfort and necessity in using cosmetics. Many cosmetics fall under the category of FMCG (fast moving consumer goods) products on the market. While some cosmetics are intended purely for personal hygiene and instant beautification. Others are used to treat certain ailments and conditions While cosmetics have been clearly defined by law, p. Personal care products bear no such official definition to be legally classified from a cosmetic. However, one thing is but very clear that a personal care produ