Cosmetics Rules Research Articles

Prevalence and Profile of Tapentadol Use in Patients Visiting a Drug De-addiction Center in Kashmir

Background: Misuse of prescription opioids has been a hazard lately with tapentadol being a recent addition to the list. Tapentadol is a schedule H1 opioid (Drugs and Cosmetics Rules, India), approved for the management of moderate-to-severe acute and chronic pain. Aims and Objectives: We examined the prevalence of tapentadol use among patients attending the Drug De-addiction Center, Government Medical College, Srinagar, Kashmir, along with their sociodemographic and clinical profiles. Materials and Methods: It was a cross-sectional study. Patients who reported current tapentadol use were included in the study. Results: In a span of 4 months, a total of 104 patients using tapentadol were seen. Our study mostly consisted of young, unmarried males. More than half of our study participants had concurrent opioid dependence. In our study, no participant had ever injected tapentadol. Conclusion: Tapentadol is becoming infamous as a cheap and ready-to-available drug, replacing other opioids during their nonavailability. This should be a potentially alarming sign for drug control authorities. As such, its sale and supply should be well regulated.

Current Status of Rule 170 in Drugs and Cosmetics Act & Rules, 1940 & 1945

Drugs and Cosmetics Act, 1940 (Act 23 of 1940) is a pre-independence Act passed by British Legislature under the Government of India Act, 1935 as the Drugs Act, 1940. The main objective of this act is to regulate the import, manufacture, distribution and sale of Ayurveda, Siddha, Unani drugs. The Drugs and Cosmetic Rule came in existence as a part of force vide Notification No.F.28-10/45 (H) (1), the 21st December, 1945, Department of Health, Government of India, New Delhi. Drugs and Cosmetic Rules, 1945 composed of 19 parts containing 170 rules. The rules 151 to 170 are pertaining to Ayurveda, Siddha, Unani drugs. The review aims to get a transparency regarding the current status of Rule 170 of Drugs and Cosmetic Rule, 1945, as this rule is in a state of uncertainty. Rule 170 and its provisions 0f Drugs and Cosmetic Rules, 1945 mainly deals with the prohibition of misleading advertisement of Ayurveda, Siddha or Unani drugs. On 29th August 2023 the notification from Ministry of Ayush in relation to the omission of Rule 170, creates dilemma in public. In that notification it is clearly stated that, With the power confers under section 33P of Drugs and Cosmetic Act, 1940, all States/UTs licensing authorities are here by directed not to initiate or take action under the Rule of 170 of Drugs and Cosmetic Rules, 1945. Together with this notice it also mentioned that the notification for omissions of Rule 170 and its related provisions mentioned in Drugs and Cosmetic Rules, 1945 will take some time. The letter was issued based on a recommendation from the ASUDTAB and developed based on the existing case regarding the Patanjali products. A part from this in “THE INDIAN GAZETTE” of 2nd February 2024, Ministry of AYUSH notified the draft of certain rules further to amend the Drugs Rules, 1945. In that over the serial number 33 mentions regarding the omission of Rule 170, it is quoted like “The Rule 170 of the principal rules, shall be omitted”. As per the objection/opinion received from the public over the drafted rules published by Ministry of Ayush in relation to Drugs and Cosmetic Rules, 1945, a latest notification of “THE INDIAN GAZETTE” (July 2nd of 2024) also suggesting that “Rule 170 shall be omitted”. By reviewing this, it is found that still the Rule 170 is not get omitted from the Drugs and Cosmetic Rules, 1945, instead of omission it got neutralised based on the section 33P of Drugs and Cosmetic Act and it is on consideration for omission.

The effects of Jawoongo soap on skin improvement.

Jawoongo is used to treat and prevent skin issues such as dry and keratinization disorders, burns, trauma, pigmentation, scarring, and inflammatory skin conditions. In this study, the efficacy and safety of 0.47% Jawoongo extract-containing soap (JAUN-CS) were assessed in terms of skin improvement effects such as cleansing, moisturizing, sebum secretion management, and skin elasticity enhancement. Twenty healthy adult men and women aged 20-60 years old took part in the study. Before and after using JAUN-CS, the participants were divided into groups, and various skin improvement effects were measured utilizing machines such as the Corneometer, Tewameter TM 300, and Visioscan. A dermatologist analyzed the product's safety in accordance with Frosch & Kligman and the Cosmetic, Toiletry, and Fragrance Association (CTFA) rules. Using JAUN reduced the amount of base and point makeup by 25.7% and 76.7%, respectively. Also, JAUN showed a great facial exfoliation effect by removing the old and lifted skin keratins by 84.7% and 20.3%, respectively. Impurities in facial pores decreased by 58%, too. Furthermore, JAUN increased the moisture content of deep skin and skin surface by 3.5% and 74.0%, and skin elasticity by 2.8%. Skin tone, skin texture, skin radiance, and skin barrier all showed improvements of 3.3%, 20.0%, 15.0%, and 115.2%, respectively. Lastly, cleansing with JAUN successfully enhanced the condition of the youth triangle by 7.6%, while TEWL significantly decreased by 52.7%. Neither the JAUN nor the control group soap showed any adverse reactions, such as erythema or allergies, during the testing period. The results of this study demonstrated that JAUN is safe for human use and has various skin-improving properties, making Jawoongo a promising natural material for the development of functional cosmetics in the future.

Decoding Cosmetic Complexities: A Comprehensive Guide to Matrix Composition and Pretreatment Technology.

Despite advancements in analytical technologies, the complex nature of cosmetic matrices, coupled with the presence of diverse and trace unauthorized additives, hinders the application of these technologies in cosmetics analysis. This not only impedes effective regulation of cosmetics but also leads to the continual infiltration of illegal products into the market, posing serious health risks to consumers. The establishment of cosmetic regulations is often based on extensive scientific experiments, resulting in a certain degree of latency. Therefore, timely advancement in laboratory research is crucial to ensure the timely update and adaptability of regulations. A comprehensive understanding of the composition of cosmetic matrices and their pretreatment technologies is vital for enhancing the efficiency and accuracy of cosmetic detection. Drawing upon the China National Medical Products Administration's 2021 Cosmetic Classification Rules and Classification Catalogue, we streamline the wide array of cosmetics into four principal categories based on the following compositions: emulsified, liquid, powdered, and wax-based cosmetics. In this review, the characteristics, compositional elements, and physicochemical properties inherent to each category, as well as an extensive overview of the evolution of pretreatment methods for different categories, will be explored. Our objective is to provide a clear and comprehensive guide, equipping researchers with profound insights into the core compositions and pretreatment methods of cosmetics, which will in turn advance cosmetic analysis and improve detection and regulatory approaches in the industry.

REGULATORY LANDSCAPE OF UNANI PRODUCTS UNDER D&C ACT AND RULES

The Unani System of Medicine (USM), deeply rooted in tradition, undergoes scrutiny in India under the Drugs and Cosmetics Act (D&C Act) for consumer safety. Regulated by the Central Drugs Standard Control Organization (CDSCO) and guided by the Ayurvedic, Siddha, and Unani (ASU) Drugs Technical Advisory Board, this framework ensures Unani product safety, efficacy, and quality. Manufacturers must comply with Good Manufacturing Practices (GMP), and the D&C Act establishes standards for labeling, packaging, and quality control—essential for marketing Unani products in India. The paper aims to analyze key D&C Act provisions related to Unani formulations, focusing on regulatory procedures. The study sheds light on specific requirements governing Unani drug import, manufacture, distribution, and sale, offering valuable insights into the regulatory framework. It systematically examines the D&C Act, emphasizing sections related to Unani products. Unani Drugs must adhere to prescriptions in the 14 recognized Unani texts (Schedule I of D&C Act). The Drugs and Cosmetics Rules of 1945 cover Unani Medicine in Parts 16 to 19, addressing licensing (Part 16), testing (Part 16A), labeling and packaging (Part 17), and quality control standards (Part 19). In conclusion, this paper provides a nuanced analysis of the regulatory landscape governing Unani products under the Drugs and Cosmetics Act. It elucidates legal intricacies, emphasizing challenges in compliance, standardization, and merging traditional knowledge with contemporary requisites. The insights contribute to understanding the regulatory environment surrounding Unani medicines, balancing cultural heritage preservation with ensuring efficacy and safety for consumers.

Role of the National Control Laboratories in Ensuring the Quality, Safety and Efficacy of Blood Products in India

National control laboratories (NCLs) are responsible for testing of the batches of drugs prior to their release on the market. NCLs play an important role in strengthening a country’s regulatory systems. The National Institute of Biologicals is an NCL in India for the testing and coenzyme A (CoA) release of biologicals such as biotherapeutics, vaccines, and diagnostic medical devices. Every year, the National Institute of Biologicals tests and CoA releases thousands of batches of blood products following compendial specifications and schedule F, part XII-C (G) of Drugs and Cosmetics Rules 1945. This institute also participates in collaborative studies with the WHO for the establishment of international reference standards. In the last thirteen years (2010–2022), the blood products laboratory at this institute has evaluated 5159 batches of blood products, and 95 batches (1.84%) were declared as not of standard quality. As per CDSCO “the ‘not of standard’ quality products are categorized into three categories: A, B and C”. These 95 batches include all three categories (A, B and C) of “not of standard” quality blood products.

An Overview on Vegetable Origin Drugs Used in Ayurveda, Included in the Schedule (E1) of the Drugs and Cosmetics Rules, 1945

The Drugs and Cosmetics Rules, 1945 are the rules which Government of India framed under the Drugs and Cosmetics Act,1940. The objective of the act is to regulate the quality, safety and efficacy of the drugs and cosmetics sold in India. Schedule (E1) of the rules enlist the poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine. The present work is an overview on the vegetable origin poisonous drugs used in Ayurvedic system of medicine. Methods: A thorough evaluation of literature was done, including the relevant portions of the Drugs and Cosmetics Rules, 1945, authoritative text books of Ayurveda, published research papers in reputed journals. Results: Schedule (E1) is related to Rule 161(2) of The Drugs and Cosmetics Rules, 1945; which instructs that if an ASU medicine contain any one of the Schedule (E1) drug as an ingredient, its label must contain a caution note, warning the user that it should be taken only under medical supervision. 14 vegetable origin drugs are categorized under the list of poisonous substances in Ayurvedic system. All these drugs have promising therapeutic utility which was also proved by various researches. Even though included in Visha-Upavisha varga (group of poisonous substances), these drugs are not toxic as Ayurveda advocates the unique processing method of Shodhana (purification) before using them therapeutically. Effect of Shodhana (purification) was also proved by various researches. Conclusion: Ayurvedic medicine, containing Schedule (E1) drug as an ingredient should be sold and used only under valid prescription of a registered physician. They are to be manufactured only after proper Shodhana (purification) of the poisonous ingredient. Caution label should be there on the medicine bottle. Physicians must ensure judicious usage of these medicines by giving proper patient education regarding the dosage and duration of administration.

Regulatory overview on New Drugs and Clinical Trials Rules, 2019

Most clinical studies were carried out in the United States, Europe, and Japan up until 1995. In 1995, the first assessment of research in India was completed. A 2004 article suggested that India lacked the ideal research environment that the majority of clinical researcher’s demand. Clinical trials carried out in India significantly increased in 2009. A public interest litigation (PIL) was filed in 2012 accusing government, non-governmental, and independent investigators of conducting clinical studies improperly. The Drugs and Cosmetics Rules of 1945's Schedule Y, which govern clinical trials, were previously followed (D&C Rules). The Drugs and Cosmetics Act, 1940 (D&C Act) is the legal framework for the New Drugs and Clinical Trials Rules, 2019, or "NDCT Rules," which put an end to the protracted process of codifying the regulations that apply to clinical trials. Clinical trials, studies on bioequivalence and bioavailability, ethics committees, and investigational novel medications for human use will all be subject to the new regulations. As of 13-01-2o22, the Union Health Ministry has published a final notification revising the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to include cell derived products as well as stem cell derived products under the definition of new medication.

Fixed dose combinations in India- what a way to go!

Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity having peak efficacy at different time zone, (c) Chemical non compatibility leading to decreased shelf life, (d) Drug interactions due to common metabolizing pathways, and (e) limitations of dose titration of individual ingredients. As per Rule 122 E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs where the Central Drugs Standard Control Organization (CDSCO), ensures proper clinical data is submitted for the approval into the market. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) mentions the requirements for marketing approval of various types of FDCs.

Analysis of Variation in Blood Donor Deferral Section Statistics as per Drugs and Cosmetics (Second Amendment) Rules, 2020: An Institutional Experience

Introduction: The safety of donated blood is of utmost importance for the well-being of the recipient, which requires proper adherence to donor acceptance criteria. In March 2020, new amendments were introduced in the Drugs and Cosmetics Act, which included several new criteria. It is important to explore these changes and their impact on the donor pool to ensure adequate maintenance of whole blood/component inventory in our blood centre. Aim: To study the variation in deferral statistics of blood donors after the introduction of new donor criteria as per the Drugs and Cosmetics (Second Amendment) Rules, 2020. Materials and Methods: The present study was conducted from October 1, 2022, to June 30, 2023, in the Department of Immunohaematology and Blood Transfusion (Blood Centre) of a tertiary care hospital in Punjab, India. Retrospective data for three years was collected from blood donor records and deferral records, divided into two groups: group 1 (October 1, 2018, to March 31, 2020) for the old criteria, and group 2 (April 1, 2020, to September 30, 2021) for the new criteria. Reasons for deferral of donors were categorised into four stages: clinical history, medical examination, investigations (hemoglobin levels), and inadequate collection for both male and female donors. The collected data was entered into a Microsoft Excel sheet. Variables in different categories were represented as frequencies and percentages. Chi-square test was used for comparison between the data of the two groups. Results: In group I, 332 out of 6,588 donors (5.04%) were deferred, and in group II, 345 out of 6,143 donors (5.61%) were deferred. The deferral rate was comparatively higher in females in both groups, with 17.98% (41/228) in group I and 21.65% (21/97) in group II. The percentage of deferred donors was higher in the age group of 18-30 years in both groups, with 50.60% (168/332) in group I and 47.25% (163/345) in group II. The maximum number of donors were deferred at stage I (clinical history), with 270/332 (81.33%) in group I and 296/345 (85.8%) in group II, followed by stage III (investigations), with 34/332 (10.24%) in group I and 33/345 (9.56%) in group II. COVID-19 related history was the third most common cause of deferral in group II, accounting for 43 (12.46%) of the total deferred cases, which was not present in group I. Conclusion: The new guidelines, although comprehensive, only minimally increased the deferral rate and did not have a significant impact on the donor pool of our blood centre. Knowledge about the latest deferral guidelines and donor deferral rates is of utmost significance for the maintenance of inventory and to reduce the loss of a significant donor pool.

Vaccines development in India: advances, regulation, and challenges.

One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body's defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher's knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

BLOOD DONOR DEFERRAL PATTERN AS A KEY TOOL FOR SAFE BLOOD TRANSFUSION PRACTICE: A RETROSPECTIVE STUDY FROM NORTH EAST INDIA.

Background: Safe blood transfusion practice starts with meticulous selection of blood donors. Recruitment and retention of healthy safe donor is crucial to maintain adequate supply of blood units available for transfusion. The present study was undertaken with the aim to analyze the rate as well as the causes of pre-donation deferral and blood units discarded following screening test for Transfusion Transmitted Infection (TTI). Material and methods: This retrospective hospital-based study was conducted in the Blood Centre, Jorhat Medical College and Hospital, Jorhat, Assam over a period of one year i.e., from 1st October, 2021 to 30th September, 2022. All donors who attended the Blood Centre as well as outdoor voluntary blood donation camps were included in the study. Each and every blood donor was screened as per the guidelines of Drugs and Cosmetics (Second Amendment) Rules, 2020. Transfusion Transmitted Infection (TTI) screening tests were done on the collected blood units and those found to be positive were discarded. The donor records were reviewed and analyzed according to sex, donor type (voluntary or replacement) and reason for deferral. Results: Out of 17030 prospective donors, 14372 (84.39%) donors were accepted for blood donation while 2658 (15.61%) donors were deferred. The deferral rate was higher in females i.e., 35.63% (88 out of 247) compared to males i.e., 15.31% (2570 out of 16783). Deferral percentage of voluntary donors was 19% (2563 out of 13485) and that of replacement donor was 2.68% (95 out of 3545). The rate of temporary and permanent deferral was 99.17% (2636 out of 2658) and 0.83% (22 out of 2658) respectively. The most common cause of temporary deferral was found to be low hemoglobin (41.81%) whereas in case of permanent deferral high risk behaviour (50%) was found to be the leading cause. 3.21% (462 out of 14372) blood units were discarded following screening tests for Transfusion Transmitted Infection (TTI). Hepatitis C was the most common cause of blood units discarded. Conclusion:Asystematic and well organised approach to selection of blood donors is the mainstay of safe blood transfusion practice. Analysis of donor deferral pattern guides us to recruit safe healthy donors and to maintain an adequate pool of blood units available for transfusion

Schedule T – Good Manufacturing Practice of Indian systems of medicine

On June 23, 2000, the Government of India issued GSR No. 560(E) under Rule 157 of the Drugs and Cosmetic Rules, and on March 7, 2003, GSR No. 198(E) revised Good Manufacturing Practices (GMP). These rules were made necessary for all new ASU drug manufacturing facilities on June 23, 2000, and for existing units on June 23, 2002. (2 years grace period was given for existing ASU units to obtain GMP certification). The criteria for production premises and hygienic conditions are outlined in Schedule T. The fundamental goal of implementing Schedule-T was to ensure that producers maintained a consistent level of hygiene. Good manufacturing practises must be followed at all times. For all the manufacturers of ASU drugs. Compliance to Good manufacturing Practices is mandatory for all the manufacturers of ASU drugs.

Analysis of Knowledge, Usage and the Practice of Total Body Care Cosmetic Products in Western Province; Sri Lanka

Cosmetic care product are used for skin, hair and nail caring practices. The cosmetic product regulations in Sri Lankan regulatory authorities is not properly implemented for importing and marketing thus it is needed to prevent the misuse and related adverse events. As an initiative, our team investigated data on knowledge of cosmetic care, and the practicing methods of the participants in western province in Sri Lanka as a phase 1 study. It was a descriptive cross-sectional survey and participants aged from 18 to 70+ years were openly invited. Informed consent was included in the self-administered questionnaire, validated before proper research. It includes questions on knowledge, attitudes, and practice of cosmetic usage. Our data showed that majority were female (71%), age group of 18-39 yrs (93%). 92% of them are Sinhalese, and 17% of Musilms. 93% of participants were aware reasons for using cosmetic product and 68% of them were aware composition of and adverse effects. 93% of them were aware about risk of allergy and 89% of them uses skin and body products. Average using time was more than 5 years by 39% and 31% used it for 1-5 years, rest of them less than one year respectively. Use of cosmetic is mainly for minor skin abnormalities (24%) and to enhance the appearance (16%) others included both reasons (60%). Majority had used both herbal and cosmetic products (63%). 61% of them preferred both local and international products. Most of them had referred social media for the selection of the product. We concluded that participants from western province showing expected personal knowledge on composition, indications, and potential adverse effects. This data is important to consider for preparing cosmetic rules and regulations and also recommend proper scientific based audio and visual educational program in selection process.

Comparative Analysis of New Drugs and Clinical Trial Rules 2019 and its impact on Approval process of Oncology Drugs

With the aim to make India as the hub for Clinical Trials and promote a transparent and faster drug approvals process for the early availability and accessibility of drugs in the country the New Drugs and Clinical Trials Rules were published on March 19, 2019. The subsequent amendments were also proposed from time to time from March 2019 till June 2022 to make the regulations and the processes more robust.
 The ‘New CT Rules’ replaced the Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. The NDCT rules will be applicable to all Investigational New Drugs, Biologicals, New Drugs, and Subsequent New Drugs. These rules also laid down the procedures for the effective working of Ethics Committees. The ‘New Rules’ comes up with many desirable changes that will bring transparency, predictability and well defined requirements to speed up the drug approval process in India. The New CT Rules provides a defined protocol so that decision making becomes uniform and that mainly focuses on the Quality & Safety of Clinical Trials. With these rules in place the regulatory system aims to make India a global clinical hub, approvals for the drugs with predictable, transparent and effective regulations and to make faster availability of new drugs to Indian population. In this article, we have highlighted the key developments/changes in the revised regulatory pathway for clinical trials in India and brought the comparative analysis of what has changed from the previous rules till date as subsequent amendments were also notified from time to time. Also, the present work aims at providing the impact of NDCT rules 2019 and subsequent amendments on approval process of drugs for life threatening diseases, unmet medical need and rare Diseases like Cancer. 
 By these rules in place Indian pharmaceutical industry would be able to bring a number of medicines which could be promising and effective in treating this pandemic for which no country in the world has been able to find any cure so far. The clause for local CT waiver, accelerated approval, reduced times for CT application is like a boon for developing new drugs in India. This will ensure faster availability of drugs in the country for life threatening diseases, unmet medical needs and rare disease like Cancer. Thus, proving it right that NDCT rules and subsequent amendments brought to the rules will be developing the country’s reputation across the globe and will harmonize the regulations in line with the International standards.

A quality audit of the medicinal package insert information of drugs marketed in India

Background: A package insert (PI) accompanying medicinal products is a concise and accessible source of evidence-based information for health professionals and consumers alike. In India, the supplied information should be adequate and fulfill the statutory regulations of the Drug and Cosmetics Rules (1945) to ensure the safe and effective use of the drug. Aim and Objectives: The present observational study aimed to evaluate the uniformity and adequacy of information on PIs available in India. Materials and Methods: PIs of approved and marketed drugs were collected from pharmacies and analyzed with the help of a 30-item checklist comprising of components of statutory guidelines and other quality indicators. Each item was assigned a weightage of two if the information was complete, one if inadequate, and 0 if absent. The total score was calculated for each PI. Results: The median score of the 150 analyzed PIs was 41 (Inter quartile range, 36.00–45.25) out of a maximum value of 60. The major deficiencies observed were in providing missed dose instructions (91.33%), further reading resources (84.67%), supporting references (83.33%), and drug disposal instructions (76%). Other notable missing information were laboratory parameter interference (68.67%), clinical trial data (62%), adverse drug reaction reporting contact information (56.67%), and a list of excipients (49.33%). Conclusion: There are important inadequacies in the clinical information provided in Indian PIs which can affect patient health and hinder rational drug use. Thorough evaluation and revision of the PIs is warranted to make them more reliable and popular among users.

A Critical Analysis Study of Pharmacological and Clinical Information Provided in Drug Package Inserts Based on Drugs and Cosmetics Rules Guidelines

Introduction:Drug package inserts are officially approved documents provided along with the drugs by the drug marketing company. They act as an important source of information about the drug for both patients and physicians, which helps in proper administration and improving the safe use of medications. The pharmacological and clinical information presented in them for its consistency and completeness were analyzed in this study.Materials and Methods: The drug package inserts were collected and analyzed for the pharmacological and clinical information, based on the headings under Section 6.2 & Section 6.3 mentioned in Schedule D of Drugs and Cosmetics Act and Rules, 1945. The drug package inserts that were analyzed in this study included different drug formulations and drugs belonging to different systems.Results: This study shows that the generic name, the brand name of the drug, its active ingredient, therapeutic uses, dosage form, and manufacturer details are present in all the package inserts (100%). But details about safety and precautions are given only in about 90%. Information about pharmacokinetics, pharmacodynamics, pharmaceutical particulars, and the antidote for drug overdose are missing in many package inserts.Conclusion:From our study, we conclude that a majority of the package inserts provide adequate details regarding key information. However, we recommend mentioning the approximate cost of the drug, references for the information provided in it, along with the Toll-free number of the Pharmacovigilance Programme of India (PVPI) for reporting adverse drug effects.

New drug and clinical trial rules, 2019: an overview

<p>Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review gives an idea about the recent changes regarding the regulations of clinical trials.</p>

Analysis of completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies: an Indian perspective

Background: A package insert (PI) should contain all the information required for safe and effective use of the medicine. The present study evaluated and compared the completeness of information in package inserts of Indian and foreign multinational pharmaceutical companies based in India.Methods: A total 150 PI’s consisting of 75 package inserts of Indian and foreign multinational pharmaceutical companies in India were collected and analyzed based on the criteria of Indian drugs and cosmetics rules, 1945 under section 6.2, 6.3 of schedule D, which consists of 25 parameters. Each criteria was scored for presence of information as ‘1’, absence as ‘0’. Total score was 25, score >20 was graded as ‘A’, 10-20 as ‘B’ and <10 as ‘C’. Data was expressed as numbers and percentage.Results: Total 150 PI evaluated included antimicrobials, antipsychotics etc. Out of all the PIs 26% belonged to grade A, 70% belonged to grade B and 4% belonged to grade C. Lack of information was found in both the categories of PIs. Foreign PIs performed better in comparison to Indian PIs as in grade A, 27 out of 41 PIs were foreign whereas 56 PI’s in grade B were Indian and 47 were foreign. Both categories of PI showed good information about active ingredient, dosage form, warnings, contraindications and lacked information about retail price and references etc.Conclusions: Both categories of PIs were deficient in completeness of information. The pharmaceutical companies, both national and foreign, must provide the information as per regulatory norms.

A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B)

Background: Product labels are considered as clinical instruction manual which plays a vital role in providing information to the prescriber and end-user at a glance. As Ayurvedic drugs fall under the purview of the Drugs and Cosmetics Act, 1940, a set of quality criteria-based information is required to be displayed on the labels of Ayurvedic product containers marketed in India. Aim and Objective: In the present study, containers of different Ayurvedic products dispensed at Government hospitals and sold at private pharmacies in Bangalore were selected and checked for their compliance with labeling guidelines as mentioned in Drugs and Cosmetic Act 1940. Results: Among 150 selected products, 78 products were classical preparations and 72 were proprietary medicines. Among the fourteen criteria derived from labeling guidelines mentioned in drugs and cosmetic act, all the 150 products were following the standard guidelines with respect to the six basic criteria like name and address of the manufacture, net weight of the formulation, batch number, license number, date of manufacture and mentioning of the word Ayurvedic medicine. Conclusion: Even though majority of the labels of Ayurvedic drug containers fulfilled the requirements, a good number of Ayurvedic products are still not in accordance with the regulatory requirements in providing label information. Following a strict compliance in some labeling specifications like providing complete details of ingredient with their net weight in metric system, displaying the caution warning for formulations containing schedule E 1 drugs, providing the expiry date, and citing the reference from authentic texts in case of classical formulations is still lacking.