Central Drugs Standard Control Organization Research Articles

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 & 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
 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.

Knowledge, attitude and practice towards adverse drug reactions reporting in post graduate students of a tertiary care hospital

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.

Compassionate drug use: Current status in India.

The World Health Organization defines compassionate use (CU) as a “program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope.” Over the years, an increasing number of requests and isolated cases have paved the way for more robust CU programs by pharmaceutical companies and guidelines by eminent regulatory bodies globally. In India, although there is no formal mention of the term “Compassionate Use” by the Central Drugs Standard Control Organization, there are provisions in the Drugs and Cosmetics Act 1940 and Rules 1945 to allow drugs to be imported as and when necessary. Such applications can be submitted to the Drug Controller General of India by a hospital, patient, or a pharmaceutical company. The evidence of such use of drugs is underlined by the availability of bedaquiline and delamanid for extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB patients, respectively. CU is in its nascent stage in India owing to the lack of policies and laws needed to govern it. There is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.

A study on drug induced cutaneous adverse drug reactions at a tertiary care hospital, Mysore, India

Background: Drugs, however safe and efficacious, are associated with risk of adverse reactions. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs was rated as the fifth leading cause of death among all diseases. Consequences of ADRs range from diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of the study were to obtain information about drug induced cutaneous adverse reactions and to establish the causal relationship.Methods: Observational cross sectional study, a total of 76 patients were recruited for the study,conducted in dermatology outpatient department of K R Hospital Mysore Medical College And Research Institute Mysore for 3 months. The drug reactions were recorded in ADR form of Central Drugs Standard Control Organisation (CDSCO). Causality was assessed using Naranjo algorithm and World Health Organization- Uppsala monitoring centre (WHO-UMC) criteria.Results: 76 patients with CADRs were included in the study during the 3 months study period. Most common age group with CADRs was 20-30 years; with 55.73% of females 20.26% male and the most common suspected drug group causing CADRs was antimicrobial 35.46%. And most common lesion is maculopapular rashes. According to Naranjos scale 67.30% of CADRs were probably caused by drugs.Conclusions: variety of drugs causes CADRs. Awareness among clinicians is required for active reporting of CADRs. Patients need to be educated for the cautious use of drugs causing ADRs to prevent the same.

Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases.

Purpose:The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional Ethics Committees (IECs). Rule 122DD of the Drugs and Cosmetics Act (and Rules) mandates that only registered ECs can accord approval for regulatory studies. We evaluated the current status of registered, reregistered, and accredited ECs in the country to assess the impact of both the recommendation and rule.Materials and Methods:Websites of stakeholders-the Central Drugs Standard Control Organization (CDSCO), National Accreditation Board for Hospitals and Healthcare Providers (NABH) were assessed. Information on registration status was then compared with regulatory clinical trials in the Clinical Trials Registry of India, population demographics of all states, and the Medical Council of India recognized postgraduate medical colleges in the various states.Results:A total of 1268 ECs were registered with CDSCO. Of these, 1008 (79.5%) were institutional and 256 (20.18%) independent ECs. A total of 499/1268 (39.4%) ECs were reregistered. Of which 449/499 (90%) were institutional and 50/499 (10%) were independent. Institutional ECs were five times more likely to be reregistered with CDSCO relative to independent ECs (cOR 4.52 [3.12, 6.54], P < 0.0001). A total of 15/233 (7%) applications to NABH had received accreditation. A wide skew was seen in the distribution of ECs across various states as also their oversight of regulatory clinical trials.Conclusions:Registration and reregistration of ECs along with accreditation is not commensurate with the needs of the country at this time and must be vigorously promoted.

Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and hospitalizations have consistently increased, leading to economic burden to developing countries like India. Identification of ADRs and their reporting pattern can provide useful information for their management. Aims and Objectives: The objective of the study was to assess the pattern of ADRs in tertiary care teaching hospital with respective to various parameters. Materials and Methods: The present study was an observational, prospective study. ADR reports of 40 patients were collected from various clinical departments of Dr. D. Y. Patil School of Medicine, Navi Mumbai. The ADRs were collected during January 2018–July 2018, with ADR reporting form of Central Drugs Standard Control Organization, New Delhi. Data were analyzed using descriptive statistics. Results: A total of 40 ADRs were reported during this study; the mean age of the patients being 43.14 (±2.27) years. Gender distribution of the patients showed 26 (65%) female preponderance. The majority of ADRs were implicated to pulmonary department 13 (32.5%) and least in OBGY 2 (5%). Using Naranjo’s causality assessment scale, there were 24 (60%) probable, 12 (30%) possible, and 4 (10%) doubtful/unlikely causality of the ADR with the suspected offending drug. Conclusion: We conclude that antitubercular, injectable iron, pentavalent vaccines, and psychotropic drugs are responsible for most of the ADRs and middle-aged population are most commonly affected with ADR. Completeness score was an average of 32.2 ± 2.6. The completeness score can be improved if the reporter spends sometime considering its their moral responsibility.

Vaccine pharmacovigilance in India: Current context and future perspective.

Pharmacovigilance of vaccines is of paramount importance to promote the safe use of vaccines among their recipients. India launched the Adverse Events Following Immunization (AEFI) surveillance program in 1986 for monitoring suspected adverse events following immunization and since then, the AEFI surveillance guideline has been updated periodically, with the latest being in 2015. The successful AEFI surveillance program in India required the concerted effort of all stakeholders such as National AEFI Secretariat, National Technical Collaborating Centre, Central Drug Standard Control Organization, marketing authorization holder, and health-care professionals.

Central institutional ethics committee needed to facilitate timely review of multicenter clinical trials.

A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored.

An audit of minutes of Subject Expert Committee meetings as a metric to assess the clinical research roadmap of India.

Background:In January 2015, the Drugs Controller General of India approved the formation of 25 Subject Expert Committees [SEC] to aid the office of the Central Drugs Standard Control Organization [CDSCO] with regards to decision making. The present study is an audit of the minutes of the meetings the SECs held over the past three years.Methods:All minutes during the period 1st July 2014 to 31st October 2017 were accessed from the CDSCO website. Applications were classified as those for clinical trials [CT] and those for marketing authorization [MA]. Each application was classified as being approved, amendment requested for or rejected.Results:A total of n = 317 meetings were held over a 40 month period with n = 2616 agenda items. The Oncology/Hematology SEC had the maximum number of meetings at n = 48 [15.1%]. Only n = 2030 [77.6%] were evaluable agenda items. There were 1082 [53%] applications for clinical trials, and 948 [47%] applications for MA with or without a request for a clinical trial waiver[CTW]. Applicants seeking CTW were 5 times more likely to be rejected [for the waiver] relative to those not seeking waivers (cOR 5 [3.8, 7], P <0.001). CTW applications for Oncology were 6.5 times more likely to be granted a waiver (cOR 6.5 [3.5, 11.7], P <0.001). Considerable variability was seen in the minutes.Conclusion:A vast majority of CT applications in the country receive approval, as do a majority of marketing authorization applications. Oncology, vaccine and opthalmology division predominate the approvals. There exists considerable heterogeneity in the minutes. Standardization of these minutes across committees will help add to the existing transparency and give greater insights into the decision-making process.

Pharmacovigilance: The Least Understood and Least Practiced Science in Dentistry

Aim: The purpose of this review was to explore the overall scenario of pharmacovigilance, its aims, challenges, and recommendations pertaining to dentistry for further improvements. Materials and methods: Literature search was done with the help of the Endnote software, followed by vigilantly arranging the material in a coordinated way. Results: Adverse drug reactions (ADRs) are among the top 10 leading causes of all-cause mortality. In order to reduce the harm to the patients and serve the public health mission, there is a definite need for developing mechanisms for evaluating and monitoring the safety of medicines in India. Therefore, the requirement for developing a well-organized pharmacovigilance system is imperative. Different countries have developed their own reporting guidelines for pharmacovigilance. The reporting guidelines are conceived to adapt to the specific requirements of any country and the prime focus of these adverse event reporting systems is improving the patient’s health and safety. The Central Drugs Standard Control Organization (CDSCO) has initiated a nation-wide pharmacovigilance program in India. It aims to protect the health of the patients by assuring drug safety under the aegis of Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. In dentistry, the science of pharmacovigilance is rarely applied and its practice among dental health professionals, including reporting of ADRs, is minimal. However, studies have shown that the dental professionals comprehend the importance of pharmacovigilance and its application in dentistry. Conclusion: It is essential to foster a sense of trust among patients regarding the medicines they use, to ensure that risks in drug use are anticipated and managed. This will eventually enhance the confidence of patients on the healthcare delivery system in general. Clinical significance: The practice of dentistry involves prescribing various medications for patient use. It is therefore the duty of the dentist to comprehend and identify the adverse effects of the drugs. Dentists should also know about the right channel for reporting any instances of ADRs. They should also strive toward increasing the awareness among patients regarding possible side effects so that any untoward consequences can be avoided. This will be an invaluable aid in furthering the public health mission of improving the health of the populations.

FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES

India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector.Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts fortotal quality management as primary criteria to prevent sub-standard products which do not fall under officialspecifications. However, there are many areas where immediate regulatory measures are desired. Central DrugsStandard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement accordingto the Drugs and Cosmetic Act 1940 and Rules 1945, with its amendments. There is no established system formonitoring the Physician’s samples as it generally moves from medical representatives to patients via medicalprofessionals. Fixed dose combinations are approved by Drug Controller General of India without proper doseschedule and indications. Metered dose inhaler is presented without dose counter, so that user cannot read how manydoses remain. The capacity of CDSCO/the licensing authority/ controlling authority at both national and state levelneed to be matched with Pharmaceutical Industry in term of man power, infrastructure and training to provide safeand effective drugs to the patients. In the present review, those areas have been highlighted along with some possiblesolutions such as more stringency and uniformity in drug regulatory policies, use of software to identify duplicate andmisbranded medicines, speedy functioning of drug regulatory authorities etc.

Fixed dose combinations of anti-tubercular, antimalarial and antiretroviral medicines on the Indian market: critical analysis of ubiquity, sales and regulatory status.

To assess the proportion and sales of unapproved Fixed Dose Combinations (FDCs) of anti-tubercular, antimalarial and antiretroviral medicines available on the Indian market. Available FDCs of anti-tubercular, antimalarial and antiretrovirals were screened against the Central Drugs Standard Control Organization (CDSCO) database of approved FDCs. The FDC sales information in the given categories was obtained from AIOCD AWACS PharmaTrac, a market database. FDCs available in India were also screened against the National List of Essential Medicines India 2015 and the Orange Book Database of products approved by USFDA. Of 110 available first- to fourth-line anti-tubercular FDCs, only 32 were approved. Of 20 antimalarial FDCs available, eight were approved. However, almost 95% of available antiretroviral FDCs and branded products were approved. The sales volume of all anti-tubercular drugs was 730 million units of which 71% were unapproved, amounting to 14.30 billion rupees in sales value (58%). Almost half of the sales value and volume of antimalarials was generated by unapproved products. About 1% of sales volume of antiretroviral FDCs came from unapproved formulations, accounting for 5% of sales value. A large proportion of FDC formulations available in India has never been approved by CDSCO, hence raising the doubts about their safety and efficacy. An opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned.

A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India

Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.

Pharmacovigilance programme of India: revival of the renaissance

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

Pharmacovigilance Program of India: history, evolution and current status

Summary Unlike developed nations most of whom put into place systems of pharmacovigilance in the early 1960s following the thalidomide disaster, India's Pharmacovigilance Program formally began only in the mid-1980s. After several unsuccessful attempts, a robust program was put in place by the Central Drugs Standard Control Organization in 2010 called the Pharmacovigilance Program of India. Today, this is a stable system with the Indian regulator at the helm, a formal legislation in place to support the program and a National Coordinating Center located at the Indian Pharmacopoeia Commission. In the 8 years since its resurrection, the activities have expanded by leaps and bounds. There are 250 adverse reactions monitoring centers throughout the country and India contributes 1.7% of Individual Case Safety Reports to the Uppsala Monitoring Center's database. The WHO, recognizing India's concerted efforts in the area of pharmacovigilance, established its first WHO Collaborating Centre for Pharmacovigilance in Public Health Programs and Regulatory Services at the National Coordinating Center. The proposed expansion of the program in the coming years will further strengthen the cause of medicines safety in the country in line with the WHO's Third Global Patient Safety Challenge of Medication without Harm.

A prospective study of adverse drug reactions in a tertiary care teaching hospital

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.

India seeks to legitimize stem cell use

India proposes to legitimize stem cells and stem-cell-based products and categorize them as drugs, the health ministry announced last month. The proposal follows guidelines developed by the Indian Council of Medical Research (ICMR), which has been advocating for stringent rules for stem cell use. “Protection of human subjects participating in clinical studies is sacrosanct,” says Geeta Jotwani, deputy director general of ICMR, a research arm of the health ministry. Doctors and stem cell practitioners welcomed the move to regulate stem cell use, which will eliminate unethical players from the market, says Bhagat Singh Rajput, an orthopedic consultant and stem cell transplant surgeon at the HCG Apex Cancer Centre, Mumbai, and a vice president of India’s Stem Cell Society. The rules will pave the way for treating people who have Duchenne muscular dystrophy or spinal cord injuries, Rajput adds. India’s Central Drugs Standard Control Organization said in an April 4 notification