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  The National Pharmaceutical Pricing Authority or NPPA has capped the price for oxygen concentrators. With the help of the trade margin rationalization approach. It has been capped at the first point of sale of a product known as the price to the distributor according to the prescribed formula by invoking paragraph 19 of Drugs Prices Control Order 2013. It is because of the enhancement in demand because of the pandemic. An oxygen concentrator is a non-listed medical device and, at present, under the individual licensing framework of CDSCO. It falls under the purview of medical device regulations in India . Moreover, due to the pandemic, the government has marked it as an important commodity and fixed its price. The formula that has been prescribed for the Maximum retail price is Price to distributor + (PTD *TM) + applicable GST, TM = Trade margin that does not exceed 70%. It is also recommended that the manufacturer's cap MRP of the oxygen concentrator submit all data contai

  The pharmaceutical and the life science industry have been the point of public discussion in this time of the pandemic. The whole enterprise's role was vital not only for the development of different treatment methods or vaccines for Covid -19 but also to make sure that supplies for another kind of disorder remain uninterrupted. The regulator of drugs also acted rapidly and definitively at the time of pandemic to make sure that all pharmaceutical companies receive the necessary support so that they can maintain an adequate supply of medicines. Coronavirus still poses a threat to the whole global population. It spreads very quickly, and a large volume of the population is vulnerable to it. The vaccine offers some degree of protection by training the body's immune system to fight the virus. Because of this, the world raced to develop an efficient vaccine to end the pandemic. But for proper development, there are some necessary regulatory guidelines . This document of guid

  India's Ministry of Health and Family Welfare has proposed a draft notification identifying American Standard Test Methods (ASTM) as one of the standard tools for demonstrating the conformance of medical devices to safe practices and forgetting the market access country. This new notification would modify India Medical Device Rules 2017 , especially the medical devices' product standards. It will increase the competitiveness of native medical devices internationally. As per the existing regulations in India, only ISO and I.E.C. international medical devices are recognized. Recognition of the ASTM devices will provide manufacturers with an extra option for representing conformance as an essential part of their device registration with the Central Drugs Standard Control Organization (CDSCO). After this modification, the rules would be called Medical Devices (Amendment) Rules 2021. These rules will come into force on the date of their ultimate publication in the required off

The Union health ministry plans to modify the New Drugs and Clinical Trials (NDCT) rules 2019 for E compassionate utilization of novel unapproved drugs depending on the Drugs Technical Advisory Board (DTAB) recommendations. DTAB measured the draft notification about the same dated June 5, 2020, after proper consideration is recommended to alter the rules, including some of the provisions for compassionate utilization of novel drugs that have not obtained approval. After a discussion with DTAB, the central government had released draft guidelines on June 5, 2020, about making some alterations in NDCT rules, 2019, for compassionate utilization of novel but unapproved drugs. It has also asked for suggestions on the draft guidelines from the industry. DTAB explained that the depiction of the Cure SMA foundation of India had been received to make the rules and guidelines for the compassionate use of novel but unapproved drugs in India. The whole illustration clearly mentioned that the

Government has extended the validity of the import license along with the registration certificate by six months. This step has been taken to make sure the medicines are available in the country. On July 27 2020, the Ministry of Health and Family Welfare gave a notification affirming that drug supply should not be affected and it should remain accessible to the public. So, due to the ongoing pandemic, COVID-19 pharmaceutical companies have wished for extending the validity of the registration certificates for about six months. Thus, exercising the powers deliberated by section 26B under Drugs and Cosmetics Act, 1940, the central government directed a notice, without withstanding anything in the rule 28A of the Drugs and Cosmetics Rules, 1945 for drugs import for the sole purpose of sale or distribution. That if an existing registration certificate holder as per given rules applies for a fresh registration certificate before expiry of the present, the present certificate will remain v

On September 8 2020, DCGI instructed all manufacturers to follow a definite procedure for regularization of FDCs or fixed-dose combinations. It has directed all to follow a specific pathway for submitting applications of the rational FDCs. CDSCO or the Central Drugs Standard Control Organization has allotted six months to all existing as well as new manufacturers for submission of application for getting the manufacturing as well as marketing approval for FDCs that has been declared rational by DTAB committee The letter depicts that if a manufacturer gives the copy of the product license that has been issued by an SLA to any of the firm specifying that the product in a specified dosage form, as well as strength, has obtained a license before November 28 2007, the same is considered for issuing permission by CDSCO office as per defined pathways. The whole procedure is the same for all FDC including the 3 that have been added recently in the rational FDC list. The pharma market of In

  A novel drug makes a great contribution to the welfare of human beings, as it helps in treating a disease or by enhancing the lifestyle of a patient. It also helps in prolonging the life of a person who is suffering from diseases that are not curable. But with every novel drug is associated the risk of side effects. This risk is one of the important concerns in association with proper regulation in the pharmaceutical sector. Such risk can cause detrimental effects for which was accepted as one of the important points to undertake for better regulation. A novel drug means novel molecular entities but in reality, it takes varied forms starting from reformulated generics to some fixed-dose combinations of the existing drugs. It has been provisioned now that all kinds of study that involves humans that are not drug trials will be under the regulation of national ethical guidelines for biomedical and health research. It is now compulsory that ethics committees should be registered with

The Union Health and Family Welfare Ministry has issued a notification on the execution of Drugs and Cosmetics Rules 2020 that states that marketers and manufacturers are responsible for giving assurance about the quality and regulatory compliances of the marketed drugs in the country with regulatory process for import and export of drugs in India . On February 13, 2020, the Ministry of Union Health and Family Welfare made a declaration for replacing a clause that contains the definition of "Marketer" which implies a person who is an agent or in any other capacity that adopts any drug that is manufactured by any other manufacturer under an agreement for drug marketing by labelling his name on the drug label given its sale and distribution. In addition to this amendment, Rule 83C, Rule 84D and Rule 84E have been inserted in the Drugs and Cosmetics Rules, 1945 for defining agreement for marketing and responsibility of marketer of the drugs. The rule 84E comprises responsibi

You may have come across the word active if you have spent some time looking through the mountains of beauty blogs out there. A quality skincare product should have an appropriate concentration of at least one active ingredient in it. Effective ingredients should be used as vitamins, moisturizers, exfoliants, and photo-aging treatments. How to define and what an active ingredient is? In a substance, an active ingredient that solves the issue it is intended to target. When you test them, it is not always clear if they work for you. Yet engaged people have far more to say than just that. When the topic is about cosmetic products, then the active ingredient term is no longer applicable. Since the term ‘active ingredient’ would classify it in the category of drugs and not relevant for processing under a cosmetics license .   In certain cases, ingredients are classified in the lower order of concentration, i.e. the ingredients at the top of the list in the highest amounts, and so on.

CDSCO or the Central Drugs Standard Control Organization has recently made it clear about the need for the process validation report to obtain the permission to conduct Clinical trial/ BA-BE studies. Under this notification, it has ordered all state drug controllers to submit the bioavailability- bioequivalence study agreements for export in 15 days along with approvals for production as well as imports of novel drugs and its complete analysis in seven days. Clinical trials and BA-BE studies are an important part of the regulatory process of import and export of drugs in India . The permission needed to do BA/BE analysis of all novel drugs for the sole purpose of export is given by the Central Licensing Authority (CLA), according to the New Drugs and Clinical Trial Rules, 2019, in the form CT-07. Import license in the form Ct-17 is also given for import of the analyzed drug. The approvals manufacture new and/or unapproved API and finished formulations for doing clinical trials (C

  Hand sanitizer has become an important part of our lives and this is now available everywhere. Starting right from the big pharmacies to small shops, they are now available for the general public. These sanitizers fall under the purview of drug product registration in India . Before Covid-19 it was mostly considered a novel product and was used by very few people. But after the pandemic, the market became flooded with a ton of hand sanitizers that claim to kill germs. Such was the impact that the government had to finally intervene and put a cap on prices. As per the latest guideline, an efficient alcohol-based hand sanitizer must have alcohol between 70-80 per cent. A hand sanitizer that contains 70% isopropyl alcohol is the best one to disinfect the hands. As per FDA guidelines the hand sanitizers should have a specified level of 80% ethyl alcohol or 75% of isopropyl alcohol and according to WHO, hand sanitizers should contain 80% alcohol and 75% isopropyl alcohol. As per DCG

The Ministry of Health and Family Welfare on March 16, the year 2020 has banned the import of two important drugs in India beneath the power given by the Drugs and Cosmetics Act, 1940. These two drugs are Chenodeoxycholic acid and Ursodeoxycholic acid. They are no more eligible for pharmaceutical product registration in India . The reason behind the ban is that both drugs Chenodeoxycholic acid and Ursodeoxycholic acid which is extracted and then prepared from porcine sources are more likely to possess a certain risk to the health of living beings that includes both human beings and animals. Thus it was necessary for Government to expedient to prevent the drug import as per public interest. These two banned drugs are extracted from the biles of domestic pigs as well as the Asian black bears. China also possesses farms for bile extraction but these farms have got severe criticism from international global animal rights organizations because of the inhumane and unhygienic extraction p

The vitality of drug trials for the promotion of health services can't be over accentuated. Novel drugs, as well as therapies can enhance the quality of life as well as the patient lifespan. While it is true that clinical trials are rapidly increasing with evolving science, the Government of India is also making sure that the safety of all subjects are well protected and the quality of trials that are done in India evolves to international standards. But before we talk about the recent changes made in medical device regulations in India for clinical trials, you should learn what a clinical trial is and what its phases are. A clinical trial is a systematic study for generating data for verification of the clinical and pharmacological profile or any kind of adverse effect of a new drug on humans. A clinical trial is one of the efficient ways to establish safety as well as the efficacy of a drug before it is introduced for general use. It is preceded by trials on animals where th

In a notification released on 11th February, 2020, the Central Government in consultation with the Drugs Technical Advisory Board(DTAB) classified medical devices as drugs w.e.f 1 st April, 2020. The definition of devices to be classified as drugs cover all existing medical devices being sold in the market, ranging from disposable syringes to MRI and CT Scan equipment. Prior to this notification, only 23 medical devices were classified as drugs and were required to undergo the deliberate registration and analysis procedure. The devices shall also be registered in CDSCO's online registration system from now. However, using the online the registration system will be voluntary for a period of 18 months and mandatory thereafter. What’s Good? While the drug license registration process is very detailed and comprehensive application procedure, involving months of careful analysis, trials and approvals. Medical devices(mainly low and medium risk) enjoyed a more lenient proce

Following promulgation released by the Ministry of Health & Welfare in October 2019. Amendments have been made to the Medical Device Rules, 2017 relating to the registration procedure of medical devices. These amendments are an addition to the Chapter III of Medical Device Rules, 2017 and will hence be classified as Chapter IIIA of these rules. These have already come into effect on 1 st April 2020 and may be called Medical Device(Amendment) Rules, 2020. According to the new rule, medical devices referred in sub-rule(1) shall be registered with the Central Licensing Authority through an identified online portal established by CDSCO for this purpose. This will be known as the “Online System for Medical Devices” and will allow the manufacturers or importers of medical devices to obtain registration numbers online. The required documents for the submission of such applications are the same as before and have to be uploaded in scanned digital format to the portal. Some commo

To ease the overall drug license registration process , CDSCO has now allowed manufacturers to use existing CMC data for their new manufacturing facilities of the same drug. This is a good step towards easing the registration process and encouraging pharma companies to expand in India. For a long time, CDSCO has been pondering over existing norms related to CMC data and license approval requirements for manufacturing a new drug by a manufacturer in an additionally owned site. Recently, the CDSCO has drafted some provisions allowing a drug manufacturer to produce a drug in their additional manufacturing units using the existing CMC data. However, the manufacturer must establish similarity through technology transfer concerning the manufacturing process. In addition to the technology transfer, some other conditions must be established between the added manufacturing site and the already approved site. Which include ●        The equipment used at both manufacturing site

Summary: The updation of information by CDSCO will ensure a more transparent and measurable transit of vaccines imported for testing. While obtaining the drug test license for importers is still a time-taking and tedious procedure. This is still an appreciable step in the right direction. Biologicals are big complicated substances that are produced by making use of recombinant DNA technology. Vaccines are an immune system stimulating drugs and fall under the category of biologicals. CDSCO or the central drugs standard control organization plays a very important role in the regulation of the manufacture and import of vaccines in India. This not only helps in making sure they are safe, efficient and of good quality but also helps in enforcing rules on the companies that make them. Since vaccines are an important component of the drugs and pharmaceutical industry. Their import, manufacture, and sale have to be strictly regulated and observed to ensure public health sa

Summary: The up gradation of the processes and norms associated with clinical trials is a good initiative taken up by the government. This will not only improve the credibility of the process but will also improve the drug license application process as a whole. DGCI has made some additional measures for streamlining the conductance of clinical trials in India by easing some prevalent sturdy regulations. This step has been taken to make sure the trial subjects are safe and receive appropriate preservation of their rights. DCGI updated these measures in such a manner that it became more favorable to conduct clinical trials in India, thereby creating a very conducive environment for both the applicant and the authorities.   This will help India with entering smoothly into a string phase of drug discovery and the proper address of novel diseases. As a concurrence, It will significantly reinforce the trust of patients in getting safe and good quality medicines at reaso