Regulating the Pharmaceutical Sector - Current Scenario and Main Challenges

1. Regulating the Pharmaceutical Sector - Current Scenario and Main Challenges Dr. B R JAGASHETTYB.Sc; M.Pharm; LLB; Ph.D Drugs Controller, Karnataka State 04.10.2013

2. Ironies of life • The lawyer hopes you get into trouble. • The Doctor hopes you fall ill. • The Police hopes you become a criminal. • The teacher hopes you are born stupid. • The coffin maker wants you dead. • Only A THIEF wishes you prosper in life

3. Current Scenario of Pharmaceutical sectors India's pharmaceutical market grew at 15.7 per cent during December 2011. Globally, India ranks third in terms of manufacturing pharma products by volume. According to McKinsey, the Pharmaceutical Market is ranked 14th in the world. By 2015 it is expected to reach top 10 in the world beating Brazil, Mexico, South Korea and Turkey. More importantly, the incremental market growth of US$ 14billion over the next decade is likely to be the third largest among all markets. The US and China are expected to add US$ 200bn and US$ 23bn respectively.

4. C D S C O – Functions • It is headed by Drugs Controller General of India • Is responsible for Standards of drugs, Market Authorization, clinical trials, cGmp • Approval of new drugs and clinical trials • Import Registration and Licensing • Licensing of Blood Banks, LVPs, Vaccines, r-DNA products & some Medical Devices • Laying down regulatory measures & amendments to D &C Act and Rules

5. C D S C O – Functions • Banning of drugs and cosmetics • Grant of Test License, Personal License • Testing of Drugs by Central Drug laboratories • Laying down standards of drugs, cosmetics, diagnostics and devices. • Publication of Indian Pharmacopoeia • Coordinating the activities of the State Drugs Control Organizations to achieve uniform administration of the Act and policy guidance.    • Guidance on technical matters. • Monitoring adverse drug reactions (ADR).  

6. C D S C O – Functions • Conducting training programmes for regulatory officials & Govt. Analysts.   • Screening of drug formulations available in Indian market.   • Evaluation / Screening of applications for granting No Objection Certificates for export of unapproved / banned drugs.

7. State Drugs Control – Functions • It is headed by Drugs Controller • Licensing of drug manufacturing and sales establishments. • Licensing of drug testing laboratories • Approval of drug formulations for manufacture • Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state. Investigation and prosecution in respect of contravention of legal provisions. • Administrative actions. • Pre- and post- licensing inspection. • Recall of sub-standard drugs.

8. Approval of Clinical Trials, Import, & Manufacture of New Drugs • Requirements and Guidelines - Schedule Y • Permission to import new drug – Rule 122 A • Permission to manufacture new drug – Rule 122 B • Definition of Clinical trials – 122 DA • Definition of New Drugs – 122 E – New substance having therapeutic indication • Modified or new claims, new route of administration for already approved drug • Fixed Dose Combination

9. HATHI COMMITTEE REPORT 1975 • Build up Testing facilities for combined food and drugs and center should assist finance • Legal-cum-intelligence cell – Spurious drugs - Maharastra, Karnataka, Gujarath & West Bengal • States should have adequate no of Inspectors with proper salary, sufficient to attract good talents and they should have proper knowledge of preperations of injectables, antibiotics, vaccines, sera etc. • The officer overall in-charge of Drugs Control in a state constitutes kingpin of organisation. Hence he should have adequate knowledge • Drug Advisory Board shall be constituted comprising representative from medical profession, police dept, social workers, industry and trade

10. MASHELKAR REPORT 2003 • A new structure for the Drug Regulatory System in the country including the setting up of a National Drug Authority • Measures to strengthen the drug regulatory infrastructure in Centre and States • Health Food/Dietary Supplements/Therapeutic Foods • Over The Counter Drugs (OTC) - Schedule K should be reviewed comprehensively. Products, which by virtue of their long usage and /or nature of their application (e.g substances used for household cleaning and disinfectants generally used in a diluted form and not meant for direct application on human skin) could be considered for inclusion in the exempted category under schedule K to further facilitate their easier access to the public at large. • Medical Devices and Diagnostics • Drug Development including Clinical Research

11. MASHELKAR REPORT 2003 • Storage and Distribution - State Licensing Authorities should devise suitable standard operating procedures to restrict excessive concentration of retail/wholesale outlets. • The drug manufacturers should follow good storage practices for their products during transport as well as their depots. • The drug manufacturers should have limited number of main stockists. Only these main stockists should sell to the retailers or hospitals. • The manufacturers should ensure that retail and wholesale chemists are aware of proper storage conditions of their products.

12. MASHELKAR REPORT 2003 • PROBLEM OF SPURIOUS AND SUBSTANDARD DRUGS - Evaluate the Extent of Spurious and Sub-Standard Drugs and Recommend Measures Required to Deal with the Problem – Whistle-blower scheme to be extended to state officers • Recommended Action by the Consumer and other Professional Associations - There is an urgent need for an awareness campaign to educate the consumers and the medical and paramedical professionals. The Committee, in particular, recommends that the Consumers and health professional / associates should play an active and visible role to create awareness about the hazards of spurious drugs. They should undertake campaigns at the national level to educate the public on the ways and means of detecting spurious drugs and the advantages of purchasing from licensed sources with valid cash memos.

13. MASHELKAR REPORT 2003 • The Committee observed that in India, because of numerous licensing authorities (State/UT’s), the implementation of drugs laws has been weak and non-uniform even after 56 years of enforcement. It is well established that the regulatory infrastructure in many States is below par, while it is functioning better in some. This has resulted in lack of adequate confidence among the consumers and level playing field for industry. The Committee observed that the issue of non-uniformity of enforcement at the state level was serious and needs to be addressed immediately. The Committee records that there should have been a single agency to regulate the manufacture and quality control of drugs in the country and that it should be done centrally.

14. MASHELKAR REPORT 2003 • 1. Division for Regulatory Affairs & Enforcement • 2. Division for New Drugs & Clinical Trials • 3. Division for Biological & Biotechnology Products* • 4. Division for Pharmacovigilance • 5. Division for Medical Devices and Diagnostics • 6. Division for Imports • 7. Division for Organizational Services • 8. Division for Training and Empowerment • 9. Division for Quality Control Affairs • 10. Division for Legal and Consumer Affairs

15. TASK FORCE REPORT – DrPronabSen 2005 • Task Force to Explore Options other than Price Control for Achieving the Objective of Making Available Life-saving Drugs at Reasonable Prices • As has already been mentioned, all things considered, in the long run a merger of the NDA and the NPPA appears desirable and should be worked towards. The Drugs and Cosmetics Act would have to be amended for this purpose. The NADT would also be the designated authority of the government for implementation of DATA. • Ideally the NADT should be an independent regulatory agency under the Ministry of Health & Family Welfare with appropriate statutory backing from DATA, but for the immediate future it may be set up as an attached office through the issue of the necessary government orders. • The drug regulator must maintain a data base on brands and their compositions, and all brand registration of drugs must compulsorily be approved by the drug regulator. In particular, no change should be permitted in the composition of a given brand.

16. Prof. RANJIT ROY CHAUDHURY REPORT • FORMULATE POLICY AND GUIDELINES FOR APPROVAL OF NEW DRUGS, CLINICAL TRIALS AND BANNING OF DRUGS • Clinical trials can only be carried out at centres which have been accredited for such purpose. The principal investigator of the trial should be an accredited clinical investigator. The ethics committee of the institute must also have been accredited. Only those trials conducted at centers meeting these stipulations will be accepted by the Drugs Controller General of India (DCGI). • The 12 drug advisory committees which are functioning at present will be replaced by one broad expertise-based Technical Review Committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations. The Committee would be assisted as required by appropriate subject experts selected from the Roster of Experts. • The CDSCO needs to be reorganized, upgraded and strengthened if it is to perform the various functions envisaged • A Special Expert Committee should be set up independent of the Drug Technical Advisory Board to review all drug formulations in the market and identify drugs which are potentially hazardous and/or of doubtful therapeutic efficacyAND A mechanism should be put in place to remove these drugs from the market by the CDSCO at the earliest.

17. CDA Bill, 2013 • The Preamble of the Act is “An Act to regulate the import, Export, manufacture, distribution, and sale of Drugs, cosmetics and medical devices to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto” instead it may be called “The Drugs, cosmetics, Clinical Trials and Medical Devices Act, 1940” • No power for State to inspect Medical devices companies • There are 19 members in CDA out of which 7 are various deptSecrataries of GOI, DGHS, Addl or joint secretary of Law ministry & Health Ministry, 4 Experts, 4 SLAs, DCGI. However No exclusive representation for Pharmacy Association / Profession • CDA can suspend or cancel licenses issued by CLA or SLAs • DCGI will act as CLA but can not delegate his / her powers to subordinates

18. CDA Bill, 2013 • The DTAB has been reconstituted with 19 members. • Medical Device Technical Advisory Board constituted with 15 members but No state Govt. representation. • In new Section 18 the existing sentence in the beginning Viz“From such date as may be fixed by the State Govt. by notification in official Gazette in this behalf”has been deleted. • States are empowered to appoint its own SLAs • Only CLA has power to issue manufacturing licence for the drugs specified under Third schedule to this Act [section 18(3)] • No drug, cosmetics or Medical device shall be Exported without a licence from CLA [Section 18 D] • CDA can suspend or cancel licences issued by CLA or SLA (Section 33Q) • CDA is Appalent Authority [section 18 R]

19. The Health care Systems The World Over Is Under Attack • Reasons include the perception that the Healthcare Systems, Providers and Administrators are Insensitive to and Incapable of safeguarding Patient Interests. • Spurious & Fraudulent Drugs and Medical Practices further endorse this perception. • The Pharmacist says it is the Doctor’s responsibility, the Doctor says it is the manufacturer’s, the Manufacturer says it is the Governments’, everyone is passing the buck. What about the poor patient ?

20. Regulatory aspects of access to medicines The mission of regulatory authorities is to promote and protect public health. The lack of access to medicines remains a huge concern, whether these are essential medicines, vaccines, orphan drugs or drugs for tropical diseases. To facilitate access, regulators and all other stakeholders need to be actively involved in identifying difficulties and seeking solutions leading to balanced approaches to access which do not compromise public health safeguards.

21. Regulatory aspects of access to medicines • Regulators have a role and responsibility to facilitate access to drugs of public health importance including proposing changes to the respective regulations in order to facilitate access without compromising quality, safety and efficacy. • As part of the medicines approval process, regulators should carry out an appropriate risk benefit assessment to allow for adjustment to the needs and profile of the anticipated patient populations.

22. Promoting Good Regulatory Practices The issues that are necessary to promote good regulatory practices nationally and internationally include: • sustainability of resources, • optimal structure, • effective cooperation within the agency and with other agencies, • transparency and accountability, • competence in evaluating efficacy, safety, and quality, timeliness, independence, collaboration as a service provider, • sharing information, harmonization, and mutual recognition. • Sources of information and the decision process should be made publicly available whenever possible. To meet the objectives of promoting and protecting public health, Regulatory Authorities need to carry out their functions effectively and efficiently within a set of principles based on transparency and good governance.

23. Promoting Good Regulatory Practices • In many cases, regulatory authorities do not have sufficient resources to carry out these activities. Most importantly, regulatory agencies must be accountable and decision-making processes must be transparent but this needs to be balanced against the need for protecting the confidentiality of the data that has been submitted by the manufacturer. • Good Regulatory Practices thus cover an evolutionary process, with good practices built into the systems which continuously reinforce collaboration and trust. • Regulatory authorities should establish mechanisms to ensure the quality of the procedures they operate to.

24. Promoting Good Regulatory Practices • States should encourage interagency cooperation for effective implementation of drug regulation involving national regulatory authorities, customs, judiciary, police, civil society and other relevant bodies set up to protect public health. • Regulatory Authorities should formulate a clear mission statement to reinforce effective and efficient drug regulation and customer satisfaction and make use of benchmarking to improve their performance.

25. Promoting Good Regulatory Practices • Regulatory Authorities should nurture good regulatory governance (integrity, transparency, accountability, public service ethics) to establish credibility and gain confidence. • The political governance responsible for national regulatory authorities should promote teamwork, overcome bureaucracy and streamline work. • CDSCO should promote and provide technical assistance for the evaluation of regulatory capacity of regulatory authorities in order to analyse the situation and to undertake necessary corrective measures.

26. Regulatory aspects - supply of quality medicines • Access to quality medicines contributes to improving human health and promoting wellbeing. Rigorous implementation of good manufacturing practices in the production of medicines will ensure that only safe, quality products are allowed on the market. • The importance of quality has been repeatedly underlined by the occurrence of counterfeit and substandard drugs. Evidence shows an increase in production, distribution and sale worldwide of counterfeit, spurious and substandard medicines which do not comply with any quality standards. • Such products are a waste of money for the people who buy them, prolong treatment periods, increase the emergence of drug resistance and can even cause death.

27. Strengthening of regulatory frameworks • The establishment of a well-functioning national regulatory system as an integral component of effective public health leads to better patient protection through provision of medicines which are safe, efficacious and of good quality. • Cooperation, communication and trust between regulatory authorities based on common principles and harmonized approaches will strengthen the effectiveness of national regulation and international collaboration. • Transparency is an important aspect of regulatory systems and helps to build public confidence, while facilitating cooperation and information exchange among regulators. • Regulatory guidelines, procedures and criteria as well as data about approved medicines should be made publicly available to all stakeholders. • Regulatory authorities should make available to the public, in understandable language, negative and positive assessment reports (including pharmacovigilance reports).

28. Problems of counterfeits • Should adopt the WHO Guidelines on Developing Measures for Combating Counterfeit Drugs, raise public and political awareness of the problem of counterfeiting, increase national and international cooperation, data exchange between all stakeholders, including national regulatory authorities, interested nongovernmental organizations, law enforcement agencies, industries, and relevant international organizations. • In collaboration with other stakeholders, it is necessary to develop a draft concept paper on counterfeit drugs. • Doping in sports is a serious health problem and is within the remit of drug regulation. National regulatory authorities should remain vigilant and provide the necessary resources to combat such practices.

29. Extent of Spurious Drugs

30. Computerization!!! At present there is a delay due to duplication of work, lack of man power, infrastructure and therefore loss of efficiency. Enormous waste of precious man power and resources due to paper work. Lack of feedback to the citizens on the fate of their complaints.

31. Salient features of the soft ware • L.M.S • F.M.S • Category Wise Manufacturers List • Banned Drugs List • Drugs Control Officer’s List • Product Wise Manufacturers List • Forms Fee List • Approved Manufacturers List  • Manufacturers Products List • Own/Loan Wise Manufacturers List • New Drugs List • Manufacturers Licence History • Inspection Forward Report • Licence Expiry Report • Technical Staff List   

32. IT Infrastructure • Prompt and efficient recall of Not of Standard Quality / Adulterated / Spurious drugs. • Submission of monthly reports/daily diaries by enforcement officers in time. • Sending the drug alert circulars, drugs price notifications, important notifications etc., by Head Office to Sub-Offices.

33. CURRENT ISSUES FOR IMPLEMENTATION • Shortage of Manpower • Lack of Infrastructure • Lack of Funds • Lack of training facilities for officers and staff • Difficulties in the management of the existing manual filing system • Time wastage and lack of efficiency due to manual typing system

34. Solutions Requirement • Sufficient manpower and Infrastructure • Allocation of adequate budget • Inter and Intra departmental interactions and collaboration tool including file tracking and knowledge management • Tools for effective monitoring of District level / block level Officers’ performance and collection and compilation of reports • Tools for efficient training of officers and other functionaries of the department

35. CONSUMER AWARENESS • For increasing consumer awareness the senior officers of the department should participate in public meetings and impart knowledge about drug quality. • The senior officers of the department should deliver lectures in workshops being conducted for Druggists & Chemists Associations. • Each State should constitute a Drug Advisory Board comprising representative from medical profession, police dept, social workers, industry and trade.

36. EXISTING CORROSPONDANCE BETWEEN FIELD OFFICE AND HEAD OFFICE Outstanding work District wise monthly reports Head office Monthly report of revenue Receipts Case worker Expenditure Statements Details of A.C. Bills drawn Dy.Drugs Controller Shortages of drugs samples drawn Detection of spurious drugs & seizure of drugs Additional Drugs controller Tour Programs Drugs controller Daily Diary Field office Deputy Drugs Controllers /Assistant Drugs controller/ Drug Inspectors

37. PROPOSED SYSTEM OF CORROSPONDENCE BETWEEN FIELD OFFICE AND HEAD OFFICE Field Office Head office Tour Program Drugs Controller Deputy Drugs Controllers/Assistant Drugs controller/ Drug Inspectors Head office data base Outstanding work manufacturing inspection Additional drugs controller District wise monthly reports Monthly report of revenue Receipts Deputy drugs Controller Expenditure Statements Details of A.C. Bills drawn Assistant Drug controller/ Drug Inspectors Shortages of drugs samples drawn Case workers Detection of spurious drugs & seizure of drugs Tour Programs Daily Diary

38. EXISTING SYSTEM OF INVESTIGATION OF COMPLAINT SAMPLEREGISTER HEAD OFFICE Not of Std. Quality Drawl of Sample COURT REGISTER Drug Testing Lab. Investigate Seize Withdraw Std. Quality Close Complaint CLOSE OR FILE COURT

39. PROPOSED SYSTEM OF INVESTIGATION OF COMPLAINT Head Office Officers Case Workers Head Office Data Bank Complaints Std. quality Investigate, seize, Withdraw Report Drug Testing Lab File complaint or Close Draw Sample Not of Std Quality Court Trial

40. Drugs Controller (1) Pay Scale-48900-63600 Additional Drugs Controller (1) Pay Scale-40050-56550 Deputy Drugs Controller (13) Head Quarters -3 Regional Office (5) Pay Scale- 36300-53850 Chief Scientific Officer(4) Drugs Testing Laboratory Vacant (1) Pay Scale -36300-53850 Principal (1) Govt. College of Pharmacy Vacant-1, Pay Scale (37400-67000) Board of Examining Authority For Diploma students in Karnataka State Intelligence Branch Drugs Inspector (05) + 5 Pay Scale (22800-43200,) Vacant:01 Assistant Drugs Controller (60) Vacant - Nil Pay Scale 28100-50100 Scientific Officer(19) Government Analysts Vacant-10 Pay Scale 28100-50100 Professor( 6) Vacant-1 Pay Scale (37400-67000) Chairman (1) (Principal Govt. College of Pharmacy) Ex-Officio Drugs Inspectors (112) Vacant – 11 Pay Scale-22800-43200 Junior Scientific Officer (113) Vacant-30 Pay Scale-22800-43200 Assistant Professor (8) Vacant-2, Pay Scale (37400-67000) Member Secretary (1) Deputy Drugs Controller (HQ) on Deputation Gazetted Assistant (1) Pay Scale 21600-40050 Gazetted Assistant (3) Vacant-2 Pay Scale 21600-40050 Lecturer (22) Vacant-04 Pay Scale(15600-39000) Gazetted Assistant (1) Vacant:01 Pay Scale-21600-40050 Total Staff Strength of Group A.B.C.& D 288 Working Strength 206, Vacant-82 Total Staff Strength of Group A,B,C,& D 312 Working Strength -168 Vacant 152 Gazetted Assistant (1) Pay Scale-(21600-40050) Total Staff Strength Group A,B,C & D 16 Working Strength-11, Vacant-05 Total Staff Strength Group A,B,C & D : 83 Working Strength-61, Vacant-22 KARNATAKA DCD ORGANOGRAM

41. ENFORCEMENT WING – STAFF PARTICULARS

42. STATISTICS

43. STATISTICS

44. STATISTICS

45. DRUGS TESTING LABORATORY STAFF PARTICULARS

46. PERFORMANCE

47. PERFORMANCE

48. DETAILS OF PROSECUTIONS No. of Cases Filed : No of Cases Decided :

49. Steps taken by DCD, Karnataka • Separate State Intelligence Branch at State HQ has been set up to unearth and combat the menace of Spurious Drugs. Five Intelligence branches have been established in Five Regional Offices. • 32 Special Courts have been notified to try the offences related to Spurious and Adulterated Drugs In Karnataka . • Home Department of Govt. Of Karnataka has directed all the police stations in Karnataka to extend co-operation to Drugs control dept. Officers.

50. DCD, KARNATAKA