Counterfeit Regulatory Consideration


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Counterfeit Regulatory Consideration

  1. 1. Presentation by:- ATUL K NASA Drugs Control Department Govt. of NCT of Delhi Delhi – 110032 email :- [email_address] M:- 09871318288 President-IPGA Vice President-AIDCOC Joint Secretary IPCA Counterfeit Medicines – Regulatory Consideration
  2. 2. Questions <ul><li>What is Counterfeit Medicine? </li></ul><ul><li>Is it defined under Drugs and Cosmetics Act, 1940? </li></ul><ul><li>What are the Regulations in India? </li></ul><ul><li>What strategy should be adopted for curbing the menace? </li></ul><ul><li>What steps are taken by the Government for strengthening regulations? </li></ul>
  3. 3. Counterfeit Medicine - What it means? <ul><li>WHO Definition </li></ul><ul><li>Deliberately and fraudulently mislabeled with respect to its identity and/or source </li></ul><ul><li>Apply to both branded and generic products </li></ul><ul><li>Include products with correct ingredient or with wrong ingredients without active ingredients, with insufficient ingredient </li></ul><ul><li>Products with fake packaging . </li></ul>
  4. 4. Counterfeit Medicine - Exceptions <ul><li>The following situation should not be confused with counterfeiting: </li></ul><ul><li>Quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate, authorized medical products, </li></ul><ul><li>b) Patents disputes or violations arising from the international trade of products that are legitimate and authorized for marketing in their country of origin or destination .” </li></ul>
  5. 5. Counterfeit Medicine – Proposed changes <ul><li>Word medicine is proposed to be substituted by : </li></ul><ul><li>“ A medicine] / [A medical product* [medicine, vaccine, diagnostic or medical device] </li></ul><ul><li>Scope of definition is further widened by including the word Components and it is proposed that Counterfeits may include products with correct ingredients/ [components], with wrong ingredients/[components],.” </li></ul>
  6. 6. Position under Drugs & Cosmetics Act <ul><li>The term ‘Counterfeit Medicine’ is not defined under the Drugs and Cosmetics Act, 1940 </li></ul><ul><li>The terms ‘Spurious Drug’, ‘Misbranded Drug’ and ‘Not of Standard Quality Drug’ are defined separately </li></ul><ul><li>Three definitions together cover instances of counterfeiting incorporated under WHO definition </li></ul>
  7. 7. Misbranded Drug- What it means? <ul><li>If it is not labeled in prescribed manner </li></ul><ul><li>If its label or container or anything accompanying drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular </li></ul>
  8. 8. Spurious Drug- What it means? <ul><li>If it is manufactured under a name which belongs to another drug </li></ul><ul><li>If it is an imitation of or substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug </li></ul>
  9. 9. Spurious Drug- What it means? <ul><li>If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or a company is fictitious or does not exist </li></ul><ul><li>If it has been substituted wholly or in part by another drug or substance </li></ul><ul><li>If it purports to be the product of a manufacturer of whom it is not truly a product </li></ul>
  10. 10. Regulatory framework <ul><li>Deterrent punishment provided under Act by amending Act, </li></ul><ul><li>68 of 82 </li></ul><ul><li>Minimum punishment of three years which may extend to five years provided for offences of manufacture, sale and distribution of spurious drugs </li></ul><ul><li>Drugs Inspectors have sufficient powers under Section 22 of the Act </li></ul><ul><li>Procedure to exercise powers is specified and Drugs Inspector is also required to follow the procedure under the Code of Criminal Procedure while carrying out search and seizure </li></ul>
  11. 11. The Reality <ul><li>Manufacture, sale and distribution of spurious drugs is clandestine activity. </li></ul><ul><li>The manufacture and distribution is normally through unauthorized channels. </li></ul><ul><li>The tracking and trailing requires concerted efforts. </li></ul><ul><li>Cases are not generally noticed during routine inspections. </li></ul><ul><li>Normally, complaints do not result in detection of such cases. </li></ul>
  12. 12. Investigation - What it means? All proceedings for collection of evidence. It is a systematic, minute and thorough attempt to learn facts about something complex or hidden . Its starts when information in respect of an offences received.
  13. 13. Methodology <ul><li>Confidential purchase of drugs suspected to be spurious </li></ul><ul><li>Confidential testing of these samples </li></ul><ul><li>Comparison with original product </li></ul><ul><li>Wherever possible obtaining opinion of original manufacturer </li></ul><ul><li>Following suspect with the help of watcher or by officer himself </li></ul><ul><li>Decision taken to raid the place or places with or without help of police </li></ul>
  14. 14. Essential Requirements <ul><li>Independent intelligence wing to tackle the </li></ul><ul><li>problem. The wing should have dedicated </li></ul><ul><li>officers with aptitude for investigation. They </li></ul><ul><li>should have:- </li></ul><ul><li>Ability to cultivate informants </li></ul><ul><li>Communication and coordination skill </li></ul><ul><li>Presence of mind </li></ul><ul><li>Ability to remain cool </li></ul><ul><li>Patience and perseverance </li></ul><ul><li>Ability to follow clues </li></ul>
  15. 15. What needs to be done? <ul><li>Strong proactive Drugs Control Organizations </li></ul><ul><li>Establish independent intelligence branch at state level </li></ul><ul><li>Establish legal cum intelligence branch at zonal offices of CDSCO </li></ul><ul><li>Select officers in Intelligence Branch having aptitude for investigation </li></ul><ul><li>Special training in investigational skills </li></ul>
  16. 16. What needs to be done? <ul><li>Effective networking between stakeholders. </li></ul><ul><li>Creating environment of trust amongst stakeholders </li></ul><ul><li>Strengthening of laws </li></ul>
  17. 17. Drugs and Cosmetics (Amendment) Act, 2008 <ul><li>Salient features of the Act:- </li></ul><ul><li>Substantial enhancement in punishment </li></ul><ul><li>Life imprisonment for offenders involved in manufacture, sale and distribution of spurious and adulterated drug likely to cause grievous hurt </li></ul><ul><li>Minimum punishment of seven years which may extend to life imprisonment </li></ul><ul><li>Provision for compensation to affected person </li></ul>
  18. 18. Drugs and Cosmetics (Amendment) Act, 2008 <ul><li>Salient features of the Act:- </li></ul><ul><li>Corresponding enhancement in punishment for repeated offenders </li></ul><ul><li>Cognizance can be taken on the complaint of any gazetted officer authorized by Central or State Government </li></ul><ul><li>Cases to be tried by Sessions Court </li></ul>
  19. 19. Drugs and Cosmetics (Amendment) Act, 2008 <ul><li>Salient features of the Act:- </li></ul><ul><li>Designation of special Courts for trial of offences in respect of adulterated and spurious drugs </li></ul><ul><li>All offences relating to adulterated and spurious drugs made cognizable and non bailable </li></ul><ul><li>Restrictions on bail – Bail cannot be granted unless public prosecutor is heard </li></ul><ul><li>Certain offences made compoundable </li></ul>
  20. 20. Notification Dated August 10,2009
  21. 21. GUIDELINES FRAMED <ul><li>GUIDELINES FOR TAKING ACTION ON SAMPLES OF DRUGS DECLARED SPURIOUS OR NOT OF STANDARD QUALITY IN THE LIGHT OF ENHANCED PENALTIES UNDER THE DRUGS AND COSMETICS (AMENDMENT) ACT, 2008 </li></ul><ul><li>The Drugs and Cosmetics (Amendment) Act, 2008 passed by the Parliament on 5th December 2008 provides deterrent penalties for offences relating to manufacture of spurious or adulterated drugs which have serious implications on public health. </li></ul><ul><li>It will help regulatory authorities to handle anti social elements involved in the manufacture of such drugs and playing with human safety. </li></ul><ul><li>The penalty for manufacture of spurious or adulterated drugs has been enhanced to an imprisonment for a term which shall not be less than 10 years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drug confiscated, whichever is more. </li></ul><ul><li>In certain cases offences have been made cognizable and non-bailable. It also provides a tool of compounding of offences for dealing with certain minor offences. </li></ul>
  22. 22. GUIDELINES FRAMED <ul><li>Under the Drugs and Cosmetics Act, 1940 control over manufacture and sale of drugs is exercised by the State Licensing Authorities. </li></ul><ul><li>Licences for drug manufacturing establishments and sale premises are granted by the said authorities. Inspections/raids are carried out by the Drug Inspectors appointed by the States to ensure compliance of the conditions of licences. </li></ul><ul><li>Samples are drawn by Drug Inspectors to check the quality of drugs marketed in the country. </li></ul><ul><li>Legal/administrative actions as required under the said Act and Rules for the violation of the provisions of the Act are taken by the State Licensing Authorities. </li></ul><ul><li>The actions are normally initiated on the basis of test reports of Government analysts declaring the drug samples as not of standard quality. </li></ul>
  23. 23. Conclusion <ul><li>The problem of spurious drugs is a challenge before the regulatory officers, with the amendment to the Act </li></ul><ul><li>Existing provisions which are adequate are further strengthened by the Drugs and Cosmetics (Amendment) Act, 2008 </li></ul><ul><li>Concerted efforts with close coordination with all stakeholders </li></ul>
  24. 24. THANK YOU