Central Drugs Standard Control Organization Research Articles

PATTERN OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL – A CROSS-SECTIONAL STUDY

Objective: The objective of the study was to study the pattern of suspected adverse drug reactions (ADRs) in a tertiary care hospital.
 Methods: This is a cross-sectional study conducted in the Department of Pharmacology of a Tertiary Care Teaching Hospital, Kerala. As part of pharmacovigilance activities, the ADRs were collected in Central Drug Standard Control Organization Suspected ADR reporting form from various departments during a period of 3 months and recorded in Pharmacovigilance register maintained by the pharmacology department. As part of our study, we collected the details such as patient’s initials, age, gender, reporting department of hospital, description of the ADR, duration of the reaction, name of suspected ADRs, and outcome from the Pharmacovigilance register. Descriptive statistics will be used for data analysis by statistical package for the social science for windows 16.
 Results: Two hundred and twenty-two ADR from 141 patients obtained during a period of 3 months. The maximum ADR reports were in age group more than 50 years of age. The skin and appendages were most affected followed by gastrointestinal tract. Antineoplastic drugs accounted for 59.7% of drug class suspected for ADRs followed by use of more than one drug (14.1%). Among antineoplastic drugs, cyclophosphamide and carboplatin accounted for majority causes of ADR. The antibiotics accounted for 12.7% of all drugs. Among the antibiotics penicillin and cephalosporins caused most of the ADRs.
 Conclusion: The maximum number of ADR reported in our study was with the use of antineoplastic drugs and most common ADR reported was alopecia.

An Overview of World-Wide Master Key for Drug Safety Monitoring (Pharmacovigilance) and Its Role in India

Pharmacovigilance (PV) described as science & actions connecting to the identification, evaluation, awareness, & mitigation of Adverse Drug Reactions (ADRs) or associated conditions. Some serious cases of ADR contributed to the development of this discipline in the 1970s. There have been many efforts to establish such a programme in India between 1989-2004, but the system has finally begun in 2010 and is functioning successfully and achieving meaningful results. Based on the data gathered via this method, Pharmacovigilance Program of India (PvPI) contributed various data to the World Health Organization (WHO) Uppsala Monitoring Centre (UMC). They also issued some warnings to the stakeholder and made a range of suggestions to the Central Drugs Standard Control Organisation (CDSCO). CDSCO has also advised Marketing Permit Holders (MAHs) to comply with the same requirements and has introduced relevant changes to the Drugs and Cosmetics Act & Regulations. The time has arrived when Indian regulatory authorities would undertake the requisite action on the basis of data produced in our country rather than on the basis of data generated in several other countries

An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)

Background:The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as they are approved elsewhere. Against this backdrop, we assessed the absolute and relative drug lags of the Indian regulator relative to three regulators in mature markets, namely United States (US), European Union (EU), and Japan.Methods:International nonproprietary names were used to identify new drugs. Their dates of approval (2004-2018) from the online database of four regulatory agencies were identified. Both absolute and relative drug lags were calculated for India as compared to US, EU, and Japan as well for all the agencies relative to the Indian regulator.Results:We identified a total of 453, 473, 424, and 472 new drugs approved over the study period in India, US, EU, and Japan, respectively. The absolute drug lag of Central Drugs Standard Control Organization (CDSCO) was 19 and 18 relative to the US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA), respectively. The relative drug lag for the CDSCO vis-a-vis the US FDA, European Medicines Agency, and PMDA was 43.2 (2.1–1287.8), 25.6 (0.03–1310.5), and 30.3 (1.2–1242) months, respectively.Conclusion:Our study shows a significant drug lag between India and other three developed nations (US, EU, and Japan). However, in some therapeutic areas, Indian regulator has proactively approved new drugs much before other agencies. The New Drugs and Clinical Trials Rule of 2019 has brought hope for reduction in drug lag in the near future.

Evolution of Medical Device Sector in India and Comparison of Registration Processes of Medical Devices in India with Countries like China, Australia, U.S. and Europe

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments Make in India Campaign 2017, and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). In China, the registration approval process is under NMPA (National Medical Product Administration) and requires complying with Chinese regulatory standard notice No. 218. Europe and Australian regulations are bit same and require a CE (Conformité Européenne) mark for manufacturing and marketing. U.S. regulations for approving medical devices are stringent and 510 (k) and PMA (pre-market authorization) is compulsory. In this review, the reader would get an idea about the evolution of medical devices and legislative changes in India and also about international standards and auditing programs. There is a comparison of Indian, Chinese, Australian, U.S., and European medical device registration processes for understanding the similarities and differences.

Analysis of all the adverse events following immunization by CovishieldTM vaccine among healthcare workers at Government Medical College, Jalgaon

Background: The severe acute respiratory syndrome coronavirus 2 (COVID 19) is a global pandemic since December 2019. The subject expert committee of the Central Drugs Standard Control Organization made recommendations for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India ChAdOx1 nCoV-19 vaccine (AZD1222) COVISHIELD™ which was developed at Oxford University. In India, this vaccine was launched on January 16, 2021, and healthcare workers were included first in this vaccination program. Aim and Objectives: This study aimed to record and analyzes all the adverse events following the immunization (AEFI) in healthcare workers for monitoring the safety and find the correlation if any. Materials and Methods: This was a prospective observational study. After obtaining Institutional Ethics committee approval, we collected the data by phone call to the participants within 3 days after the first and second dose of the vaccine. We collected the data from 100 healthcare workers randomly with their consent. Results: The most common adverse effect found was myalgia followed by local pain at the injection site after the first dose. About 92% of participants did not react to the second dose of the vaccine. Conclusion: There were no serious adverse events after the first as well as the second dose of vaccination. More studies and monitoring are needed to find out any unexpected reactions following COVID-19 vaccination.

Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India.

The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow®. This information is then stored into VigiBase® which is the repository of worldwide ICSRs. Based on the drug safety information collected, PvPI issues alerts, recommends label change (if any), and identifies signals thereby supporting National Regulatory Authority. At national level, PvPI has developed several tools for reporting of ADRs by the stakeholders. This article provides an overview of adverse events reporting tools in India vis-a-vis selected countries around the world, based on a comparative literature search. This article also throws light upon the regulatory aspects of PV in India, findings of PvPI and its recommendations to Central Drugs Standard Control Organization, collaboration of PvPI with Public Health Programmes, future prospects of reporting ADRs in India and how it will help enhance the quality of ADR-reporting by citizens of India.

Cosmetics in US and India: Overview of Regulations and Registration process

Cosmetics, for a long period of time have been used as beauty products for the care of body and face which eventually enhances a person’s appearance. These products are usually constituted from a mixture of different chemical compounds which are synthetic as well as organic in nature. For a long period of time, these products have not come under the ambit of regulatory authorities and have gone through the markets unchecked. The way a drug manufacturing and sale process is monitored by the regulatory authorities across the world, which includes careful monitoring of clinical trials, scrutinizing research results like safety, efficacy and quality of a drug has been avoided for a long period of time in case of parameters related to cosmetics. Some groups alleged that the industry practices are flawed, that there is little government regulation, and that cosmetics contain cancer-causing chemicals and other toxicants which are harmful for human body. Rules have certainly changed over time and major countries like India have started following guidelines while giving regulatory approval to cosmetics just like USA. The U.S. (FDA) functions include the banning and restriction of ingredients for safety purposes. The Cosmetic Ingredient Review (CIR) which is an independent review board that critically evaluates chemical ingredients used in cosmetics and publishes results of its findings. Similarly in India, CDSCO (Central Drugs Standard Control Organisation) and DCGI (Drug Controller General Of India), both are responsible for evaluating the composition of cosmetic products and their safety while referring to a drafted set of guidelines known as BIS( Bureau of Indian standards) guidelines. The article focuses on various aspects considered by USA and India while giving regulatory approval to cosmetic products.

Materiovigilance Programme of India: A scheme to assure cardiovascular devices safety surveillance

The Materiovigilance Programme of India (MvPI) has been implemented to ensure the safety of medical devices including cardiovascular devices (MD-CVD). This article describes the role of MvPI surveillance system that comprehensively collects, collates and analyses the adverse events associated with MD-CVD and also its supplementing role to the Central Drugs Standard Control Organization for taking regulatory decision to reduce the health burden on account of adverse events due to medical devices to the patients based on the evidence based data. This article is expected to stimulate ethical reporting of adverse events due to MD-CVD at MvPI.

Camostat in COVID-19

Chinmoy K Bose* and Mohini Basu Author Affiliations Department of Health and Family, India Received: May 27, 2020 | Published: June 03, 2020 Corresponding author: Chinmoy K Bose, Member, Subject Expert Committee, The Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, India DOI: 10.26717/BJSTR.2020.28.004596

Association of health literacy and cognition levels with severity of adverse drug reactions in cancer patients: a South Asian experience

Background The occurrence of adverse drug reactions with chemotherapy among cancer patients is a well-documented phenomenon. However, the understanding of contributoring factors and their influence on the severity of adverse drug reactions is incomplete without the psychosocial factors affecting them. Objective The present study was done to understand if factors like Health literacy and cognition levels have an association with the severity of adverse drug reactions of cancer chemotherapy. Setting This study was done in the Department of Medical Oncology in a tertiary care hospital in India. Method Two hundred and twenty-four patients meeting the study inclusion and exclusion criteria took part in the study. Details of adverse drug reactions were collected as per the central drugs standard control organization format and severity of adverse drug reactions assessed with National Cancer Institute common terminology criteria of adverse events, version 5.0. Health Literacy and Cognition Levels of patients were assessed using standardized questionnaires, i.e., Short test of functional health literacy in adults and short portable mental status questionnaire, respectively. Data were anonymized and analyzed using Statistical Package for Social Sciences version 16.0 software. Pearson’s Chi square test (p value ≤ 0.05 was considered statistically significant) was used to study the associations. Main outcome measure The associations of Health Literacy and Cognition Levels with the severity of adverse drug reactions. Result We found that both Health Literacy and Cognition Levels had a statistically significant association with Grade 3 and above adverse drug reactions in cancer patients receiving chemotherapy. Conclusion An initial assessment of Health Literacy and Cognition Levels in cancer patients by cancer care providers can help identify patients at high risk of developing severe adverse drug reactions. Interventional measures for improving Health Literacy by healthcare providers can help reduce the overall burden of disease on the patient due to adverse drug reactions.

Study of Adverse Drug Reactions (ADRs) Occurring with the Drug Use in a Tertiary Hospital

Aim: To study the adverse drug reactions (ADRs) occurring with the drug use in a tertiary care hospital. Materials and Method: This observational study conducted over a period of four months (01-Nov-2015 to 29—Feb-2016). The Central Drug Standard Control Organization (CDSCO) suspect ADR forms (15) were distributed to all clinical departments personally in Kerala medical college hospital and research center, Mangode, Cherpullaserry. Regular visits were carried out twice a week for collecting data reports. They were then analyzed, compared with state data, national data, and international data. Results A total of 25 suspected Adverse Drug Reactions forms were reported during the period of four months of the study of the out patients and in patients departments of the hospital. Among all drugs NSAIDS, followed by Antimicrobials, Antipsychotics, Bronchodilators, Antihypertensive and oral hypoglycemic agent etc.. were reported to have adverse drug reactions. Most common route of adverse drug reactions was oral, followed by IV, IM, S/C, Topical and Inhalational routes. Reactions mostly seen affecting Skin, Gastrointestinal systems, Central nervous system, and Hematological system Most patients recovered from adverse events taking suitable measures like complete stopping the offending agent, or were prescribed antihistamines, steroids in addition Conclusion: Awareness about ADR reporting is still poor amongst healthcare professionals in India. The incidence and severity of Adverse Drug Reactions documented in our study are lower than those reported in other studies. NSAIDS comprise the major drug family associated with adverse drug reactions so should be rationally prescribed. Improved communication between the physicians and nurses with the pharmacovigillance centre in the hospital is suggested.

Critical Review and Analysis of Approval of Favipiravir for Restricted Emergency Use in Mild-to-Moderate COVID-19

The Central Drugs Standard Control Organization, the Indian drug regulatory agency, granted accelerated approval to Glenmark Pharmaceuticals to market favipiravir in mild-to-moderate COVID-19 on June 19, 2020, for restricted use. The patients should sign informed consent before receiving favipiravir. Subsequently, Glenmark Pharmaceuticals issued a press release on June 20, 2020, stating that it was a landmark development for COVID-19 patients in India and the approval was backed by strong clinical evidence supporting the use of favipiravir in COVID-19. The authors carefully reviewed the press release issued by Glenmark Pharmaceuticals, product information, and informed consent form available with FabiFlu® (Glenmark's favipiravir brand) and public notice issued by the Drugs Controller General of India. They have gone through the regulatory requirements of emergency approvals in India and the USA, WHO's clinical trial synopsis for assessing efficacy of anti-COVID drugs and emergency use authorization granted to remdesivir in the USA. They critically analyzed the efficacy data presented in favor of favipiravir in this due process. Based on the review and analysis, the authors consider that the two crucial publications quoted in the product information, Chen et al. (2020) and Cai et al. (2020), do not provide convincing evidence for the efficacy of favipiravir. The entire clinical data presented in the press release and product information do not offer undisputed support for the efficacy of favipiravir in mild-to-moderate COVID-19. Moreover, it is the right time to take policy decision and frame guidelines on how to handle emergency approvals for medicinal products in grave situations such as the COVID-19 pandemic, in India.

Intraocular devices associated adverse events reporting system in India.

Intraocular devices associated adverse events reporting system in India.

Assessment of knowledge, attitude, and practice of health-care professionals in adverse drug reaction reporting in a tertiary care hospital

Aims: A cross-sectional questionnaire survey was carried out with an aim to assess the knowledge, attitude, and practice (KAP) of health-care professionals in adverse drug reaction (ADR) reporting. Materials and Methods: The study involved health-care professionals (doctors, pharmacists, and nurses) from Navodaya Medical College Hospital and Research Centre, Raichur, during the period from September 2018 to November 2018. Data were collected using especially designed questionnaire form consisting of questions regarding KAP of ADR reporting. Results: Of 100 study population, doctors were more in number (52%) followed by pharmacists (28%) and nurses (20%). Spontaneous reporting system was not much familiar to health-care professionals as a common method used in ADR reporting (53%). Majority of the health-care professionals admitted their responsibility to report ADR (58%). Awareness about nearby ADR monitoring center, Pharmacovigilance Program of India (PvPI) of the Central Drugs Standard Control Organization, ADR PvPI app, and ADR reporting form, among health-care professionals were 48%, 12%, 40%, and 47%, respectively, which can be correlated with unsatisfactory awareness among the study population. About 52% of the study population had a neutral response to the question whether ADR reporting is a professional obligation to them. About 38% of the population think that ADR reporting is time-consuming with no outcome, and 31% of the study population expressed a neutral response to the same question. Most of the study population believed that all serious ADRs are known before a drug is marketed (56%). The practice of ADR reporting was low among health-care professionals (61%) though majority of them came across through patients experiencing ADRs (67%). Difficulty in decision-making was the main factor causing ADR underreporting (32%), followed by lack of time (25%). Conclusions: This study revealed that majority of health-care professionals have insufficient knowledge and less positive attitude which resulted in low ADR reporting.

Lopinavir/ritonavir combination therapy amongst symptomatic coronavirus disease 2019 patients in India: Protocol for restricted public health emergency use.

As of February 29, 2020, more than 85,000 cases of coronavirus disease 2019 (COVID-19) have been reported from China and 53 other countries with 2,924 deaths. On January 30, 2020, the first laboratory-confirmed case of COVID was reported from Kerala, India. In view of the earlier evidence about effectiveness of repurposed lopinavir/ritonavir against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) coronavirus (CoV), as well as preliminary docking studies conducted by the ICMR-National Institute of Virology, Pune, the Central Drugs Standard Control Organization approved the restricted public health use of lopinavir/ritonavir combination amongst symptomatic COVID-19 patients detected in the country. Hospitalized adult patients with laboratory-confirmed SARS-CoV-2 infection with any one of the following criteria will be eligible to receive lopinavir/ritonavir for 14 days after obtaining written informed consent: (i) respiratory distress with respiratory rate ≥22/min or SpO2 of <94 per cent; (ii) lung parenchymal infiltrates on chest X-ray; (iii) hypotension defined as systolic blood pressure <90 mmHg or need for vasopressor/inotropic medication; (iv) new-onset organ dysfunction; and (v) high-risk groups - age >60 yr, diabetes mellitus, renal failure, chronic lung disease and immunocompromised persons. Patients will be monitored to document clinical (hospital length of stay and mortality at 14, 28 and 90 days), laboratory (presence of viral RNA in serial throat swab samples) and safety (adverse events and serious adverse events) outcomes. Treatment outcomes amongst initial cases would be useful in providing guidance about the clinical management of patients with COVID-19. If found useful in managing initial SARS-CoV-2-infected patients, further evaluation using a randomized control trial design is warranted to guide future therapeutic use of this combination.

Critical Review and Analysis of Approval of Favipiravir for Restricted Emergency Use in Mild to Moderate COVID-19

Central Drugs Standard Control Organization (CDSCO), the Indian drug regulatory agency, granted accelerated approval to Glenmark Pharmaceuticals to market Favipiravir in mild to moderate COVID-19 on 19/06/2020, for restricted use. The patients should sign informed consent before receiving Favipiravir. Subsequently, Glenmark Pharmaceuticals issued a press release on 20/06/2020 stating that it was a landmark development for COVID-19 patients in India and the approval was backed by strong clinical evidence supporting the use Favipiravir in COVID-19. The authors carefully reviewed the press release issued by Glenmark Pharmaceuticals, product information and informed consent form available with Fabiflu® (Glenmark’s Favipiravir brand) and public notice issued by the Drugs Controller General of India. They have gone through the legal aspects of emergency approvals in India and USA, WHO’s clinical trial synopsis for assessing efficacy of anti-COVID drugs and emergency use authorization granted to Remdesivir in USA. They critically analyzed the efficacy data presented in favor of Favipiravir in this due process. Based on the review and analysis, the authors consider that the two crucial publications quoted in the product information, Chang C et al (2020) and Cai Q et al (2020), do not provide convincing evidence for efficacy of Favipiravir. The entire clinical data presented in the press release and product information do not offer undisputed support for the efficacy of Favipiravir in mild to moderate COVID-19. Moreover, it is the right time to take policy decision and frame guidelines on how to handle emergency approvals for medicinal products in grave situations like COVID-19 pandemic, in India.

Strategies adopted in conduct of clinical trials amidst coronavirus disease-2019 (COVID-19)

The conduct of clinical trials is crucial to all research stakeholders and very challenging to the investigators, study teams, and participants during (coronavirus disease-2019) COVID-19 pandemic. The main challenges include difficulties in maintaining complete adherence to approved protocol, regulatory provisions applicable guidelines, recruitment of subjects, protection of rights, safety and well-being of trial subjects (participants), is of paramount importance. The CDSCO (Central Drugs Standard Control Organization), EMA (European Medicines Agency), and FDA (Food and Drug Administration) have come out with the guidelines on the management of clinical trials during the COVID-19. This article describes the process of conducting clinical trials at Department of Clinical Trials at Madras Diabetes Research Foundation (MDRF), Chennai, during the COVID-19 pandemic. Effective strategies taken at our site include compliance with scheduled visits of subjects, laboratory testing (investigations), administration of investigational product(s), assessment of safety and efficacy parameters, reporting of SAEs (serious adverse event). These strategies could be a useful reference to investigators, doctors, and research staff across hospital sites in India and elsewhere.

Terror of 10 MB, a cross-sectional study investigates the regulation to the prospective of medical device

An instrument, apparatus, implement, machine, implant, in vitro reagent, a component part or accessory which Intended for use in diagnosis of disease or other condition, or in the cure, mitigation and treatment or prevention of disease is called medical devices. Medical devices under new rule classified as Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk) commemorating the notification of January 31, 2017 of Ministry of Health and Family Welfare which is conformity with Global Harmonisation Task Force framework. As per make in India program, the industry of medical devices is USD 5.2 billion and is contributing 4%–5% to the USD 96.7 billion Indian health-care industry. A total of 750–800 medical device manufacturers in India, an average investment of Rs 170–200 million and an average turnover of Rs 450–500 million. An online licensing portal of the Central Drugs Standard Control Organization (CDSCO) called “Sugam portal” has been launched on November 14, 2015, to file application and grant permission of registration exclusively for Medical Device CDSCO MD Online portal. By making the document submission easier, there are lot of challenges also present in “Sugam-online Portal.” One of the main challenges in Sugam Portal is that there is no provision to upload files greater than 10MB file size. The current study addresses the issues and challenges faced by medical device industry and regulators with their potential solutions and recommendations.

Assessment of adverse drug reactions to antituberculosis regimen in a tertiary care hospital

Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.

Role of NIB in connecting science to patients by assuring safe and quality anti diabetic products

In India burden of diabetes is increasing and expected to cross the 100 million mark by 2030. Therefore, the development of national policies for the prevention, treatment, and care of diabetes in line with the sustainable development of health care systems is the need of the hour. National Institute of Biologicals (NIB) responsibly assures and reviews the quality of Biological products to the end users by weeding out “Not-of-Standard-Quality” Biological Medicines from reaching Indian market, thereby safeguarding the Public Health by testing at our state-of-art-laboratory. NIB receives samples from various sources such as State Port offices, Central Drug Standard Control Organization (CDSCO), Stakeholders of biotherapeutic manufacturers, legal &amp; global tender samples. They are tested by pharmacopoeial methods or manufacturer’s method for Key Quality Attributes (KQA). The heterogeneity of products involves human recombinant biotherapeutic Insulin, Insulin Analogues, and Peptides of nearly 20 different types eg. Biphasic Insulin, Glargine, Aspart, Exenatide, Liraglutide, etc. which have their global presence for the antidiabetic patient care. Testing for quality attributes such as Identification, Potency, Purity, Stability, Related Impurity and Safety parameters along with the physiochemical test is carried out to ensure the safety, quality, and effectiveness of the product. In addition, reference standards are also being developed at NIB which serves as the measurement standards and complements the written standards in India pharmacopeia. All the testing is carried out strictly adhering to the timelines so that the quality product is delivered to meet the ever-growing public health challenge&#x0D; NIB maintains quality systems of ISO 17025 standards for continuous improvement, function as Central Drugs Laboratory(CDL). It focuses on a continuous supply of lifesaving biotherapeutics to ensure the success of the Non-Communicable Disease (NCD) programme for Diabetes.