NOTABLE ACHIEVEMENTS AND INITIATIVES TAKEN BY THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION IN THE YEAR 2014 1. STRENGTHENING OF CDSCO i. Manpower strengthening CDSCO is being progressively strengthened. The sanctioned strength of 111 posts in 2008 has been increased to 474 by 2014. At present there are 220 regular officers in position. The post of Joint Drugs Controller (India) has been filled through UPSC. Other vacant posts are being filled through UPSC / SSC. A pharmacologist has been appointed as new drugs consultant to assist in processing of applications of new drugs and clinical trials. The Government has also sanctioned the appointment of 250 contractual staff to assist the organization in coping with the work load at the Head quarter as well as zonal offices. ii. Training and workshops Thirty six training programmes / workshops on the subject related to the drug control were held during 2014 for updating the information and sharpening of the skills of the concerned officials working in CDSCO. iii. 12th Five Year Plan The revised outlay under 12th Five Year Plan for strengthening of Central Drug Regulatory System provides an outlay of Rs. 900 crores for strengthening of infrastructure of CDSCO. iv. Strengthening of Central Drug Testing Laboratories For strengthening the testing capacities of the Central Drug Testing Laboratories, the sanctioned amount of 12,84,77,206/- has already been spent on account of procurement of various equipments for these laboratories. v. Introduction of E-governance at CDSCO An Memorandum of understanding (MoU) has been signed between CDSCO and Centre for Development Advanced Computing (CDAC), a scientific society under Department of electronics and information technology, Ministry of communications and information technology for designing, developing and implementing E-governance project (information technology enabled services at CDSCO for discharging various functions at the cost of Rs. 923.40 lakhs. It includes a plan for Digitalization of various activities of CDSCO. 2. STRENGTHENING OF STATE DRUG REGULATORY SYSTEM UNDER 12TH FIVE YEAR PLAN For strengthening the State Drug Regulatory mechanism, a new centrally sponsored scheme under National Health Mission (NHM) Umbrella has been proposed with 75:25 sharing pattern for providing financial and human resource support to the States / UTs. Under the Scheme there shall be requirement of Rs. 1079 crores, in which the States share would be of 229 crores and the Central Government share would be of Rs. 850 crores. The components of expense heads approved relates to up-gradation of State Labs, expansion of existing offices, manpower accommodation and creation of new labs or mobile labs. 3. DRUGS AND COSMETICS (AMENDMENT) BILL The Drugs and Cosmetics (Amendment) Bill, 2013 to amend the Drugs and Cosmetics Act, 1940 for upgradation and restructuring of regulatory framework has been further revised in the light of recommendations of the Parliamentary Standing Committee and comments from other stakeholders. The Bill include separate chapters for clinical trials and medical devices. The draft Bill has been uploaded by the Ministry of Health and Family Welfare on its website for comments from the public. The Bill will then be placed before the cabinet for introduction in the Parliament. 4. PROF. RANJIT ROY CHAUDHURY EXPERT COMMITTEE FOR STRENGTHENING CLINICAL TRIAL REGULATIONS The Expert Committee constituted by the Ministry of Health and Family Welfare under the Chairmanship of Prof. Ranjit Roy Chaudhury had made a number of recommendations in respect of regulating the conduct of clinical trials in the country in a most authentic and transparent way. The recommendations included accreditation of Ethics Committees, investigators and clinical trial sites, procedures to be followed for review and grant of permissions for clinical trials, use of information technology to ensure transparency in the system, establishing a system of reporting of serious adverse events and compensations in case of injury or death related to clinical trials etc. Actions on various recommendations were initiated. CDSCO had issued necessary orders (14 in number) on 03.07.2014. These measures will ensure that data generated in the clinical trials is authentic while the rights of human subjects participating in the trial are well protected. 5. NATIONAL SURVEY ON TO ASSESS THE PREVALENCE OF SPURIOUS SUBSTANDARD DRUGS An All India Survey is proposed to be conducted in the country with methodology prepared by Indian Statistical Institute, Hyderabad to assess the prevalence of spurious and sub-standard drugs in the country. In the proposed survey, around 42,000 samples would be drawn from across the country which would include 15 therapeutic categories of drugs which is listed in National List of Essential Medicines (NLEM), 2011.The exact quantity of drugs to be sampled will be finalized after discussion with Indian Statistical Institute (ISI), Hyderabad and National Sample Survey Office (NSSO), Delhi. The proposed survey is to be conducted in the year 2014 and 2015. In order to conduct the survey effectively the State Drug Inspectors, participating in the survey will be identified, trained by the National Institute of Biologicals, Noida. 6. REVISION OF NATIONAL LIST OF ESSENTIAL MEDICINES (NLEM), 2011 The National list of essential medicines (NLEM) is one of the key instruments in balanced healthcare delivery system of a country which inter alia includes accessible, affordable quality medicine at all the primary, secondary, tertiary levels of healthcare. NLEM was last revised in 2011. A core committee has been constituted by the Government under the Chairmanship of Dr. V. M. Katoch, Secretary, HR & DG, ICMR for updating the NLEM, 2011. The National consultations are in progress for the purpose of finalization revision of NLEM. 7. Fixed Dose Combination There were reports that certain Fixed Dose Combinations (FDCs) of drugs were licensed by the State Licensing Authorities (SLA) without due approval of DCGI as required under the Drugs and Cosmetics Rules, 1945. The SLAs were requested by DCGI on 15.01.2013 to ask the manufacturers of such formulations to submit the data of safety and efficacy to the office of DCGI within 18 months. Office of DCG(I) had received approx. 7000 applications. 10 Expert Committees were constituted on 03.02.2014 with the approval of Ministry of Health and Family Welfare for examination of these cases. Subsequently another Committee under the Chairmanship of Prof. C. K. Kokate, VC, KLE University, Belgaum, Karnataka has also been constituted for examination of applications in a timely manner. The committees have done extensive work to examine the FDCs and the report of these committees is expected shortly. 8. PROHIBITION OF TESTING OF COSMETICS ON ANIMALS i. The Drugs and Cosmetics Rules, 1945 has been amended vide Gazette notification G.S.R. 346(E) dated 21.05.2014 prohibiting the testing of cosmetics on animals in the country. ii. These rules were further amended to prohibit import of cosmetics tested on animals vide Gazette notification G.S.R. 718(E) dated 13.10.2014. 9. RESTRICTION OF SALE OF OXYTOCIN BULK To curb the misuse of Oxytocin by dairy owners for extracting milk from milch animals, the Ministry of Health and Family Welfare issued a notification under Section 26A of the Drugs and Cosmetics Act vide G.S.R. 29(E) dated 17.01.2014 restricting the manufacture and sale of oxytocin as under: a. The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug. b. The formulations meant for veterinary use shall be sold to the veterinary hospitals only. 10.BANNING OF DRUGS Drugs about which reports are received that these are likely to involve risk to human beings or animals in the present context of the knowledge are examined for their safety and rationality through the expert committees and / or DTAB after due examination of their rationality and safety. Following drugs were prohibited during the period. a. ‘Dextropropoxyphene and formulations containing Dextropropoxyphene for human use’ (G.S.R. 332(E) dated 23.05.2013). b. ‘Fixed dose combination of flupenthixol + Melitracen for human use’ (G.S.R. 377(E) dated 18.06.2013) and 498(E) dated 11.07.2014. c. Analgin and all formulations containing analgin for human use to be marketed for restricted indications only (GSR 86(E) dated 13.02.2014). 11.CLINICAL TRIALS Various initiatives have been taken for further strengthening of clinical trial regulation to ensure the protection rights, safety and well being of Clinical Trial subjects and authenticity of bio medical data generated. Some of the initiatives are given below:- i. The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification G.S.R. 889(E) dated 12.12.2014 for making specific provisions in respect of compensation for ineffectiveness and placebo group trials and streamlining the system of reporting Serious adverse events and payment of compensation in case of injury or death during the clinical trial. ii. A system of supervision of procedure for grant of clinical trial has been put in place by constituting an Apex Committee under Chairmanship of Secretary, Health and Family Welfare and a Technical Committee under Chairmanship of DGHS in compliance to the Hon’ble Supreme Court’s order dated 03.01.2013. iii. The procedure now followed for review of Clinical trial applications is a three tier review process. The applications are first evaluated by the New Drugs Advisory Committees, now renamed as Subject Expert Committees (SECs) / Investigational New Drugs (IND) committee. The recommendations of these committees are reviewed by the Technical Committee and then approved by the Apex Committee. iv. It has been made mandatory with effect from 30.11.2013 that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, is required to be done as per directions of the Hon’ble Supreme Court on 21.10.2013. The Drugs and Cosmetics Rules, 1945 are also being amended to make audio-video recording mandatory before enrolling the clinical trial subjects. v. An Expert Committee has been constituted to examine the reports of deaths in clinical trials. The committee has prepared a formula for determining the quantum of compensation in case of clinical trial related deaths which is available in CDSCO website. vi. Expert committees have also been constituted for examination of Serious Adverse Events other than death related to clinical trials. vii. Another committee has worked out the formulae for determining the quantum of compensation in case of clinical trial related injury (other than death) and this has been approved by the competent authority. viii.An administrative order was issued by DCG(I) making it mandatory for the sponsor or his representative to furnish the detail of the contract entered by the sponsor with the investigator / institution with regard to finance support, fees, honorarium, payments in kind etc. to be paid to the investigator. ix. A system of accreditation of Ethics committees, investigators and clinical trial sites and guidelines specifying the requirements and procedures is required to be put in place. The job of accreditation has been assigned to the quality council of India. x. The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has finalized the report on Accreditation Standards for Clinical Trials for Ethics Committee, Investigator and Clinical Trials. 12. PROVISION FOR LABELING, STANDARDS ETC FOR MEDICAL DEVICES The Drugs and Cosmetics Rules, 1945 were amended vide G.S.R. 690(E) dated 25.09.2014 for making provisions for the manner of labelling, qualification of competent persons to manufacture and test medical devices, shelf life, provisions for standard to which these devices should adhere and exemptions for custom made devices for their import and manufacture. 13. SIGNING OF STATEMENT OF INTENT BETWEEN FDA USA AND MINISTRY OF HEALTH AND FAMILY WELFARE The United States Food and Drug Administration (FDA) and the Ministry of Health and Family Welfare of the Republic of India sing a Statement of Intent to strengthened bilateral cooperation in the area of regulatory system of medical products to promote and protect public health on 10.02.2014. 14.VISIT OF INDIAN DELEGATION TO VIETNAM A team of CDSCO officials visited Drug Administration of Vietnam (DV), Vietnam in June, 2014 to have first hand information on the quality complaints in respect of drugs exported from India by Indian Pharmaceuticals Companies and suggest suitable remedies. *********

MAJOR ACHIEVEMENTS OF CDSCO (JANUARY, 2012 TO FEBRUARY, 2014) o A 16 member International team of WHO, after conducting an extensive four day audit from 10-14 December, 2012 in respect of the vaccine regulatory system, has declared the National Regulatory Authority i.e. CDSCO as functional. The team includes regulatory officials from USA, France, Indonesia, Thailand, Iran and WHO (HQ), Geneva. o Serodiagnostic test kits for diagnosis of tuberculosis’ have been prohibited to be manufactured /imported in to the country with effect from 07.06.2012. o Drugs & Cosmetics Rules have been amended on 17.07.2012 providing loan licensing system for Drugs under Central Licence Approving Authority. o Goa port, Marmugao port in Goa and Air ports of Goa & Bangaluru have been notified on 17.07.2012 as port of entry for import of drugs. o The Ministry of Health & Family Welfare has received the approval of 165 additional posts sanctioned to the Central Drugs Standard Control Organization in 2013 raising the sanctioned strength to 492 with 279 Drugs Inspectors. Earlier, from a total sanctioned strength of 111 posts in 2008 with 32 Drugs Inspectors, CDSCO had increased its sanctioned strength to 327 posts with 169 Drug Inspectors in 2011. o A system of issuance of Written Confirmation Certificates by DCG (I) for active pharmaceutical ingredients (API) to be exported to EU has been introduced in 2013. o Haemovigilance Programme has been launched on 10th December, 2012 under Pharmacovigilance programme of India to track adverse reactions events and incidences associated with blood transfusion and Blood product administration (Haemovigilance). National Institute of Biologicals is the coordinating centre, for Biovigilace programme (BvP) including Haemovigilance across the country. o A system of requirement of registration of Cosmetics to be imported into the country has been introduced with effect from .1.04.2013. o . A new Schedule H1 containing specified antibiotics, anti-TB drugs and habit forming drugs has been incorporated under the Drugs and Cosmetics Rules, 1945 for having stricter regulatory control over these drugs. This will be effective from 01.03.2014 o Drugs & Cosmetics Rules have been amended on 07.11.2013 deleting the clause ‘or its inclusion in Indian Pharmacopoeia whichever is earlier’ in the explanation of rule 122E. This implies that a new drug shall be considered as new drug for four years of its first approval irrespective of whether it is included in the Indian Pharmacopoeia or not. o Drugs & Cosmetics Rules have been amended on 07.11.2013 incorporating a clause under Schedule D specifying the requirement of permission of DCG(I) for import of dual purpose items by the importers. o Sindoor has been included under Schedule S of the Drugs & Cosmetics Rules on o7.11.2013 so that it conforms to the standard prescribed by BIS. o Ketamine hydrochloride has been shifted from Schedule H to Schedule X of the Drugs & Cosmetics Rules on 07.11.2013 to prevent the misuse of the drug. o Under Pharmacovigilance Programme of India (PvPi), 60 more ADR monitoring Centre have been setup taking the total to 150ADRs Centres in the country. o It has been made mandatory Under 26 A that oxytocin shall be manufactured for sale or for distribution or sold in the manner as under w.e.f. 17.01.2014;  The manufactures of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufactures licenced under Drugs & Cosmetic Rules 1945 for manufacture of formulations of the said drug.  The formulation meant for veterinary use shall be sold to the veterinary hospitals only. o The regulatory compliance at port entry for labeling requirements has been strongly enforced by vide notice dated 04.03.2014. o A international cell dedicated to address the export related issues including investigation of complaint with respect to quality of drugs was created in January 2014. The complaints are dealt by establishing expedited mechanism for enforcements vide Order No. DCG(I)/MISC/2014 (31) dt. 05.03.2014. o Various measures have been taken to strengthen regulation of clinical trials. Details are as under:  Amendment in the Drugs & Cosmetics Rules vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines.  Amendment in the Rules vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance.  Amendment in the Rules vide Gazette Notification G.S.R. 72(E) dated 08.02.2013 specifying requirements and guidelines for registration of Ethics Committees.  An Expert Committee has been constituted to examine the reports of deaths in clinical trials. The committee has prepared a formula for determining the quantum of compensation in case of clinical trial related deaths which is available in CDSCO website.  The committee setup under the Chairmanship of Prof.Ranjit Roy Chaudhury on clinical trial and new drugs has submitted its report. The Ministry of Health & Family Welfare has examined the recommendations and finalized the action to be taken on various recommendations, the details of which have been posted on the CDSCO website.  In compliance to the Hon’ble Supreme Court’s order dated 03.01.2013, a system of supervision of clinical trial has been put in place by constituting an Apex Committee under Chairmanship of Secretary, Health and Family Welfare and a Technical Committee under Chairmanship of DGHS.  The present procedure followed for review of Clinical trial applications is a three tier review process. As per the process applications are evaluated by the New Drugs Advisory Committees (NDACs)/ Investigational New Drugs (IND) committee. The recommendations of these committees are finally reviewed by the Technical Committee and then approved by the Apex Committee on the basis of recommendations of the Technical Committee.  Further, in compliance with the order of Hon’ble Supreme Court dated 26.07.2013, consultations have been made with the Principal / Health Secretaries of the States / UTs, NHRC, Civil Societies and other stakeholders who have submitted their suggestions which are under consideration for further strengthening of regulations on clinical trials.  DCG (I) through an administrative order dated 30.08.2013 has made it mandatory for the sponsor or his representatives to furnish the details of the contract entered by the Sponsor with the Investigator/Institutions with regard to financial support, fees, honorarium, payments in kind etc., to be paid to the Investigator.  In light of the order of Hon’ble Supreme Court dated 21.10.2013, it has been made mandatory with effect from 30.11.2013 that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, is required to be done.  Draft guidelines for audio-visual recording of informed consent process have been prepared. Comments/ suggestions on the draft guidelines received from the stakeholders are under examination for finalization of the guidelines. . ************

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