FORENSIC PHARMACY EBOOK
Forensic Pharmacy - Ebook download as PDF File .pdf), Text File .txt) or read book online. forensic pharmacy. Textbook of Forensic Pharmacy By C.K. Kokate, S.B. Gokhale. MB Download ✌ If Any Download Issue Please Comment Below. Rent and save from the world's largest eBookstore. Read, highlight, and take notes, Bibliographic information. QR code for Textbook of Forensic Pharmacy.
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Forensic Pharmacy is the foundation of the structure on which the sacred profession of Pharmacy has been built up in our From Vedams eBooks (P) Ltd. Get this from a library! A Textbook of forensic pharmacy. [Thomas Dewar; Pharmaceutical Society of Great Britain.]. FORENSIC PHARMACY eBook: B S. Dr. Kuchekar, A M. Mr. Khadatare, Sachin C . Mr. Itkar: instruktsiya.info: Kindle Store.
After the formation State Pharmacy Council, the register was handed over to it. Subsequent Register For the interim period until Education Regulations were enforced in the State, the names of eligible candidates were included in the register of pharmacists on fulfilling the following criteria.
Minimum age of 18 years 2. A person satisfying conditions prescribed with the prior approval of the Central Councilor conditions entitling a person to have his name entered on the first register, provided he is a matriculate. Or A person with matriculate qualification who is a registered pharmacist in another State. Regular Register After implementation of Education Regulations framed by the Pharmacy Council of India, only a diploma in pharmacy holder of an institution approved by PCI who has undergone practical training of hours after completion of D.
There were two major amendments to the Pharmacy Act, for the purpose of registration of pharmacists in and According to the amendment to Act in , the First Register was once again opened for consideration of following categories of people for the purpose of registration as pharmacists.
Eventhough, the First Registration in such a State was closed, the persons in this category were enrolled as pharmacists in First Register provided they have fulfilled the criteria laid down for enrollment in the First Register. This clause was also applicable to the persons affected by Goa Liberation Movement who were practicing pharmacy as per requirement in First Register.
These amendments were necessitated on humanitarian grounds and to attend to genuine difficulties in preparing the First Register. However, as on today the registration of pharmacists is strictly for diploma or degree in pharmacy holders from an institution approved by PCI.
The State Pharmacy Council maintains up-to-date Register of pharmacists after collection of requisite fees including following information. The Registrar appointed by SPC makes necessary entries in the Register and issues the receipt for registration which is a documentary evidence for registration. A certificate of registration is also issued by State Pharmacy Council on payment offees. Anyone who is aggrieved by the decision of Registrar for non-inclusion ofhislher name in Register may appeal to SPC within three months and the decision ofSPC regarding registration shall be final.
The Registrar, on payment of fees, may issue duplicate certificate only on confirmation that the original is lost or destroyed. Removal of Name from Register Subjectto provisions of Section 36 of the Act, the Executive Committee may order for removal of name of a person from Register, after giving reasonable opportunity to person concerned, on following grounds: A person aggrieved by order of State Pharmacy Council for removal of name from Register may appeal to the State Government within one month and the order of the State Government upon such appeal shall be final.
Offences and Penalties Dispensing by Unregistered Person: Under Section 42 of the Act, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner. Whoever contravenes this provision is punishable with imprisonment of six months or fine ofRs.
This shall not apply to the dispensing by a practitioner for his own patients. The penalty for falsely claiming to be registered pharmacist is Rs. Appointment of Commission of Enquiry If the Central Government has any substantial reason to believe that Pharmacy Council of India is violating the norms laid down in the Pharmacy Act, or misusing the powers or indulging in the matters which are not in accordance with Statutes pertaining to the Act, the Central Government is empowered to constitute Commission of Enquiry to probe into the affairs of Pharmacy Council oflndia.
The Commission of Enquiry of three persons, two of whom shall be appointed by the Central Government, one being the judge of a High Court and one nominated by the Council shall enquire into the matters referred to it and submits its report or recommendations to the Central Government. The Government may accept the report or remit the same to the Commission for modification or reconsideration. After the report is finally accepted, the Central Government orders PCI to comply within specified time, failing which, the Central Government may take appropriate action.
At State Government level, the State Government constitutes Commission of Enquiry for State Pharmacy Council not functioning in accordance with provisions of the Act and passes such order or take necessary action as deemed fit. Salient Features The Act envisages proper planning and coordinated development of technical education system in the country and promotion of qualitative improvements of technical education in relation to planned quantitative growth.
The "technical education" covers programmes of education, research and training in engineering, technology, pharmacy, architecture, town planning, management and applied arts and crafts. The Act was enacted on 15th December, It has 6 Chapters and 25 Sections. The head office of the Council is at Delhi. The Council is represented by 51 members of which 3 are AICTE officials, 15 Ex-officio, 31 nominated members and 2 members of parliament elected 1.
Vice-Chairman 3. Members appointed by the Central Government Total Four members representing organizations in industry and commerce. Eight members appointed by rotation in alphabetical order to represent States and Union Territories. Four members to represent professional bodies in technical and management education and maximum two members appointed to represent other areas. Two Members of Parliament of whom one shall be elected by the House of the People and one by the Council of states.
The term of the office other than ex-officio members is for five years.
Forensic pharmacology: An important and evolving subspecialty needs recognition in India
There is a provision for filling up the vacancies and co-option of persons for particular purposes. The Council usually meets twice a year. The Council takes decisions pertaining to development of technical education; allocation and disbursement offunds; surveys for collection of technical data; formulation of schemes for technical education of women,. The Council arranges for inspections of institutions for their approval, increase in intake, starting of new institutions and change of location of institution.
Executive Committee E. The minutes of the meetings of E. C are placed before the Council for its approval. G and P. G , Management and Pharmacy. The Boards of Studies advise E. Each Regional Committee R. C is represented by Chairman, ex-officio and nominated members. The Regional Committee perfonns the duties in accordance with direction of the Council and provides necessary information to head office from time-to-time. Every Rules and Regulations made by the Council shall be laid before each House of Parliament, while it is in session for a total period of thirty days.
Salient Features Preamble There are around five hundred pharmacy colleges in the country imparting Bachelor of Pharmacy B. The course is offered by university departments, constituent colleges, Government and private colleges affliated to various Indian Universities. The Universities offering various courses in higher education including B.
It is an Act for establishment of a University Grants Commission for the purpose of effective co-ordination and determination of standards in Indian Universities. On the advise of UGC, the Central Government may notify and institution for higher education other than a university as "Deemed to be a university" for the purpose of this Act. The Commission is a body corporate having perpetual succession and a common seal, and shall by the said name sue or be sued.
The head office of the Commission is at Deihl. The Chairman should not be from amongsts officers of the Central or State Governments. Ten members nominated by the Central Government shall be as follows: The Vice-Chairman holds office for 3 years or until the age of 65 years. The term of all other members is for three years. The re-appointment of Chairman, Vice-chairman and members is possible. The Commission meets at such times and places and transact business in accordance with the regulations made under this Act.
The Commission shall have its own fund and. Powers and Functions of the Commission: The Commission, in consultation with the universities or other concerned bodies takes all such steps which are necessary for the promotion and co-ordination of higher education, determination and maintenance of standards of teaching, examinations and research in universities. The Commission is charged with following responsibilities. The Section 12A of the Act deals with regulation of fees and prohibition of donation.
The university or the college is required to be approved by UGC under section 2 f and 12 B for receiving grants. The Commission prepares budget ensuing showing the estimated receipts and expenditure and forwards it to the Central Government.
The Annual Report is prepared by the Commission once every year giving full account of its activities during previous year and the same is laid before both Houses of Parliament. The Commission shall be guided by the Central Government on policy matters relating to national purposes. In case of any dispute between Central Government and the Commission, the decision of the Central Government shall be final.
Ethical advertisement is the way of life in this competitive world of trade, and pharmaceuticals are no exception to this practice of advertisement.
Advertisement of products is day-by-day increasing because of availability of impressive advertisement channels including TV, electronic media and proactive press. However, the cut-throat competition in advertisements and unethical approach to canvassing is required to be prohibited.
Indian population, especially in rural areas, even today is greatly influenced by the so called miraculous power of magic remedies. The use of Talisman, Taits, Sacred Threads, Kavachas, different types of bone structures, Divine Bhasmas, Mantras and other so called miraculous powers is commonly witnessed by large segment of society, even today.
The practice of Bhanamati and related disorders is predominantly prevailing in tribal areas. Any advertisements orally or in writing about the cure of diseases mentioned under Schedule to this Act are objectionable. Objective It is an Act to control the advertisement of drugs in certain cases and to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities.
It was notified on 30th April, and amended in Important Definitions 1 Drug i It includes a medicine for internal or external use of human beings or animals, ii Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals, iii Any article other than food intended to effect or influence in.
A person who holds a qualification granted by an authority specified in or notified under section 3 of the Ind ian Medical Degrees Act, or specified in the Schedules to the Indian Medical Council Act, ; or. Advertisements Banned or Prohibited 1. Advertisement for procurement or miscarriage in woman or prevention of conception in woman; or.
Maintenance or improvement of capacity of human beings for sexual pleasure; or 3.
Frequently bought together
The correction of menstrual disorder in woman; or 4. The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to this Act.
Prohibition of Participation in Certain Advertisements The participation of a person in publication of following advertisements is prohibited by the Act. Penalties The penalty for first conviction is imprisonment for 6 months or fine or both. For subsequent conviction, the penalty is imprisonment for one year or fine or both. The Gazzetted Officer authorized by State Government can enter and search at all reasonable times with assistants, if any, where he has reason to believe that an offence to violation of this Act is taking place,:.
The Gazzetted Officer can examine any record, register, document or any other objectionable material. The Drugs and Magic Remedies Objectionable Advertisements Act, 45 If the offence is committed by a company or institution, all the directors of the company or the persons present at the site of offence are liable to be prosecuted.
Nothing of this Act applies to a person who proves his innocence in the court or who proves his genuine efforts to stop such an offence or if he proves his good intentions to safeguard the provisions of this Act. Advertisements Permitted The following categories of advertisements are permitted under this Act.
The leaflets or literature accompanying packaging of drugs, advertisement of drugs in medical, pharmaceutical and scientific journals are permitted on conditions that the advertisement should contain only such information as is required for guidance of registered medical practitioners in respect of therapeutic indications of the drug, it's administration, dosage and side effects and the precautions to be observed in treatment with the drug.
It shall be the responsibility of the advertiser to prove that any claim made in the advertisement with respect to the drug is true and not misleading or exaggerated. The diseases, disorders or conditions under the Schedule for which uncontrolled and misleading advertisements are prohibited are appendicitis; blindness; blood poisoning; cancer; cataract; deafness; diabetes; diseases and disorders of brain, optical system, uterus; disorders of menstrual flow.
Import or Export of Banned Advertisement The involvement of a person in import or export activities pertaining to documents of objectional advertisements is punishable under this Act.
The Central Government through the customs officer controls the import or export of prohibited materials under this Act. The custom collector shall retain the consignment of such material and dispose it of in accordance with the provision of Sea Custom Act, An aggrieved party can appeal to him within one week of the date of receipt of order of the custom collector and give him an undertaking in writing that consignment shall not to disposed without his approval.
The customs collector shall pass an order to that effect. However, if ordered by the customs collector, the objectionable consignment is required to be returned to him within ten days. Drug is an essential commodity and is required to be regulated in terms of its import, manufacture, sale and distribution. The Central Government and State Government are charged with the responsibility of providing the drugs of desired quality to the needy patients and in order to ensure this primary obligation of the Government, the network is required to be developed to root out adulterated, misbranded and spurious drugs from the society.
The origin of DCA has a very interesting historical background. The enactment of the Act was an outcome of a sustained struggle by the medical and pharmaceutical fraternity of the country in pre-independent era against the British misrule in providing poor health care system to Indian citizens. The observ. The Import of Drugs Bill introduced in was withdrawn due to heavy criticism and later on the Drugs Bill was introduced and the Drugs and Cosmetics Act, was enacted. The Rules were framed under this Act in The Act is extended to whole ofindia including, State of Jammu and Kashmir.
It is divided into 5 chapters. Schedules T of Ayurvedic Siddha and Unani medicines was introduced in All medicines for internal or external use of human beings or animals and substances used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including, preparations applied on human body for the purpose of repelling insects like mosquitoes. The substances other than food which may affect the structure or any function of the human body or used for the destruction of insects or vermin which cause disease in human beings or animals as specified from time to time by the Central Government by notification in the Official Gazette.
It means any article intended to be sprayed, poured, rubbed or sprinkled on, or introduced into, or applied to the human body or its any part for cleansing, beautifying, promoting attractiveness or altering the appearance. It also includes any articles intended for use as a component of cosmetic. Ayurvedic, Siddha or Unani Drugs. These include all medicines used for internal or external purposes or used in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibby Systems of Medicines specified in the First Schedule to the Drugs and Cosmetics Act, It is a tobacco product used for rubbing against human teeth.
It contains tobacco powder, lime and molasses alongwith red mineral matter. It is a cosmetic within the provisions of the Act. Patent or Proprietary Medicine. In relation to Ayurvedic, Siddha or Unani System of Medicine, all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha or Unani System of Medicine specified in First Schedule to the Act but does not include the medicine.
In relation to any other system of medicine including, allopathic, a drug presented in a form ready for internal or external administration of human beings or animals and which is not included for the time being in the editions of Indian Pharmacopoeia or any other Pharmacopoeia.
It is a technical advisory body represented by the Ex-officio, nominated and elected members. The total strength of DTAB is 18 representing different facets of pharmacy and medical profession in the country. One professor in.
Table 8. One Industrialist representing pharmaceutical industry to be nominated by Central Government. The term of elected and nominated members is for 3 years. The Ex-officio members hold the office so long as they are in that specific position. DTAB ordinarily meets twice a year. For certain urgent matters, DTAB can be summoned with one week's notice.
Some times very urgent matters can be, on priority basis, decided by the Ministry of Health and Family Welfare, Government of India. However, such decisions of the government are required to be ratified by DTAB within 6 months. The composition of DCC is represented by two representatives nominated by the Central Government and one representative each of the State Government and Union Territory.
It is the Statutory Analytical Laboratory for drugs and cosmetics under DCA whose decision with regards to analysis is final in the court of law. The CDL is charged with the following responsibilities.
It takes up the analysis of samples of drugs and cosmetics sent by custom collectors and different courts. As directed by the Central Government, it advises the Central Government and the State Governments and Union Territories on the matters pertaining to the analysis of drugs and cosmetics and also takes up analytical work of specific nature for samples sent by Central Government and State Governments.
It may take up the samples for analysis on payment of necessary fee for private parties, consumer organization, etc. It is engaged in the research for the development of newer techniques of analysis of drugs and cosmetics. For the analysis of following items, the Director of concerned laboratory as indicated, has all the powers of the Director ofCDL under the provisions of the Act.
Director, National Institute of Communicable Diseases: Alongwith this a memorandum filled in by the person sending the sample for analysis in accordance with the procedure laid down should be accompanied separately in the same registered post. Another copy of this memorandum is required to be sent separately with the impression of the seal by registered post to the Director. The registered post of sample and memorandum is received by the officer deputed on behalf of Director or Director himself.
The impression of the seal in both the.
The sample is required to be kept under the custody of the Director or the officer identified by him until the analysis is over and thereafter, for a period of one year. On completion of the analysis, the protocol followed for analysis, analytical results and other relevant information are sent by registered post to the concerned party.
Depending upon the urgency of the matter, priority for analysis is fixed. The decision given by CDL regarding analysis is final and not challengable in the court of law.
The Schedules to the Act. First Schedule: It comprises the list of books of references for Ayurvedic, Siddha and Unani medicines. There are 57 books of Ayurveda, 30 books ofSiddha and 13 of Un ani Tibb systems listed in the Schedule which are used for different formulations in accordance with the provisions of the Act.
Second Schedule: It comprises of the standards to be complied with for imported drugs, manufacture of drugs, their sale, stocking and storage etc. Different Forms for application to procure licence, renewal of licence, and for all other activities. Undertaking of the manufacturer or his authorized agent required to be submitted alongwith application form for obtaining a registration certificate.
Undertaking of the manufacturer or his authorized agent required to be submitted alongwith application form for registration of a bulk drug or its formulation or its import into India. Provisions for bacterial vaccines, viral vaccines, antisera, diagnostic antigens, etc.
Schedules M- II: Requirements of factory premises for manufacture of medical devices. Schedule N. List of colours, dyes and pigments permitted in cosmetics and soaps, list of colours permitted in soaps. Particulars required to be shown in manufacturing records; raw material and analytical records.
Requirements and guidelines on clinical trails for import and manufacture of new drug. They include: Form 1. Application for licence to import drugs except, schedule X Roman X and Licence for this is issues inForm Form A - Application for permit to import small quantities of drugs for personal use while, permit is issued in Form B. Form Form A - Application for test or analysis of a drug from purchaser under section 26 of DCA, and the certificate for the same is issued in Form B.
Form A - Receipt for samples of drugs or cosmetics taken where fair price is tendered. Form A - Application for grant or renewal of a restricted licence to sell, stock, exhibit or distribute drugs by retail by dealer who does not engage qualified person.
The Licence for this is issued in Form A. Form AA - Application for grant or renewal of licence to sell, stock, exhibit or distribute drugs from a motor vehicle. The licence for this is issued in Form BB. Form B. The Iicence for retail is issued in Form C, while the licence for wholesale is given in Form D. The certificate for renewal of licence is issued in Form E. The licence this by retail sale is issued in Form F while, the licence for the same by wholesale is given in Form G.
Form B - Licence to sell by wholesale or to distribute drugs specified in Schedules C and C I from a motor vehicle. Form C. Form CC - Certificate of renewal of licence to sell, stock, exhibit or distribute drugs by wholesale from a motor vehicle.
The licence for manufacture of this category is issued in Form The loan licence for manufacture of this category is issued in Form A. The licence for repack of this category is issued in Form B. The certificate of renewal of such a repack licence for sale is issued in Form B.
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The licence to manufacture Homoeopathic medicines is issued in Form C. The certificate of renewal of such a licence is in Form C. The certificate of renewal licence for manufacture is issued in Form The loan licence for manufacture of this category is issed in Form E. The certificate of renewal of loan licence to manufacture such drugs is issued in Form E. The licence for manufacture of this category is issued in Form F. Texthook of Forensic Pharmacy - Certificate of renewal of licence to manufacture other than schedule X drugs, while certificate of renewal of loan licence to manufacture such drugs is issued in Form A.
Form F. The licence for manufacture for this category is issued in Form The licence for manufacture of this category of drugs is issued in Form A. The licence for this is issued in Form C.
Application for the same is made in Form The licence for manufacture of cosmetics is issued in Form 32, Form A -Application for loan licence to manufacture cosmetics, the loan licence for manufacture of cosmetics is issued in Form A. Approval for the same is issued in Form 37 whereas, Certificate of Renewal for the same is issued in Form The Registration Certificate is issued in Form The approval for test or analysis of this category is issued in Form 48 and certificate of renewal for carrying out tests or analysis is issued in Form Licensing and Controlling Authorities Through the 9th amendment to the Drug and Cosmetic Rules in , for the first time, the requisite qualification separately for Licensing Authority and Controlling Authority are indicated under 49 A and 50 A respectively.
The qualification required for both Licensing Authority and Controlling Authority is a graduate in pharmacy or pharmaceutical chemistry or in medicine with clinical pharmacology or microbiology from university established in India and a minimum of 5 years in manufacturing or testing of drugs or enforcement of the provisions of the Act.
Inspector The Drug Inspectors are appointed both by State Government and Central Government for specific areas or for specific category of activity. There could be a set of inspectors exclusively for the manufacturing of drug formulations.
An inspector has been charged with the responsibility of ensuring strict implementation of Drugs and Cosmetics Act in the area ofhislher. The person should not have direct or indirect financial interest in any of the activities concerned with import, manufacturing, sale or distribution of drugs.
A graduate in pharmacy or pharmaceutical sciences or medicine with specialization in clinical pharmacology or microbiology from a University established in India, is eligible for the post ofInspector.
For the purpose of Schedules C and C 1 drugs, i a drug inspector with atleast 18 months of experience in manufacturing of atleast one substance specified in Schedules C and C 1 or ii a drug inspector with atleast 3 years experience in inspecting the firms manufacturing Schedules C and C 1 drugs or iii a drug inspector with minimum of 18 months experience in testing of atleast one of the substances in schedules C and C 1 in a laboratory approved for the purpose.
The requirement of these qualifications shall not, however, apply to those persons appointed as Inspector on or before 18th October, Every Inspector shall be deemed to be a public servant under Section 21 of the Indian Penal code. Subject to instructions of Controlling Authority, it shall be the duty of an Inspector authorised to inspect premises licensed for the sale of drugs.
Subject to instructions of Controlling Authority, the following duties are performed: The Inspector, except for official business or when required by law, shall not disclose any information acquired by him. Drug Inspector if required may take the xerox copies of the seized documents signed by the owner of the documents. Drug Inspector is supposed to carry a routine inspection atleast once in a year of a shop or a manufacturing unit within his area.
The inspection should be generally carried out at reasonable time preferably during working hours. The sample withdrawn or seized from drug store should be divided into 4 parts. The seizure of medicine should be carried out in accordance with the Code of Criminal Procedure, in presence of witnesses. The samples should be sealed and the seal of drug store owner should also be allowed.
In case of injectables, 4 different ampoules of same batch are seized. The payment of fair price of seized material is made to the drugs store owner or in case of refusal for accepting money, the receipt is prepared by Drug Inspector separately and the form is filled up. Any action of seizure or raid is required to be informed to Judicial Magistrate of that area immediately. Out of 4 samples confiscated, one is retained by the Inspector, one is sent to Government analyst, one is given back to drugs store owner and 4th sample is sent to the manufacturer.
The sample sent by an Inspector to Government Analyst shall be by registered post or by hand in sealed packet enclosed with memorandum in Form 18 in an outer cover addressed to the Government Analyst.
A copy of memorandum and a specimen impression of seal is sent separately to the Government Analyst by registered post. In case of raid or seizure of medicine at manufacturing unit, 3 seized samples are prepared following same procedure. One sample is retained by the Inspector for producing in court. The second sample is handed over to manufacturer and 3rd sample is sent for analysis to Government Analyst.
After receipt of report of analysis, action is taken accordingly. If the report is satisfactory, regular sale is allowed. If it is not satisfactory, further legal action is taken up. Any physical assault or a threat in writing or on telephone to Inspector while, he is discharging his duties is considered as an offence punishable with imprisonment upto 3 years or fine or both.
Government Analyst The Government Analysts are appointed by Central Government and State Government for the purpose of test or analysis of drugs and cosmetics. The person appointed should have no financial interest in import, manufacturing, sale or distribution of drugs directly or indirectly. The person should be: For persons with other qualifications under clause a or. For veterinary biological products such as antisera, toxoids, vaccines, diagnostic antigens etc.
Duties of Government Analyst. To analyse the samples sent by the Inspector, Custom Officer or other persons under provisions of Chapter IV of the Act and prepare a detailed report of analysis in triplicate. The complete protocol of test of analysis should be given. The report should be sent in 'sealed cover to custom Department or Drug Inspector as the case may be. Forward the reports to the Government about work carried out, research undertaken, publications, if any and keep the information up-to-date in drugs and pharmaceuticals.
The Government Analyst should verify the seal before taking up analysis and ensure proper custody of the sample sent fof analysis. The analytical report should be suppl ied to the Inspector or concerned person in triplicate in Form An application from a purchaser for test or analysis is made in. Import of Drugs and Cosmetics The import of drugs and cosmetics is regulated by the provisions of this Act.
Prohibition of Import of Certain Drugs and Cosmetics The following categories of drugs and cosmetics are prohibited from import: Any drug or formulation which claims to prevent or cure diseases mentioned schedule J.
Any drug or cosmetic for which manufacture, sale or distribution is prohibited in country of its origin. Any drug which is not packed or not labeled in conformity with the Rules of the Act. The import of small quantities of any drug, subject to prescribed conditions, is permitted for test, analysis or personal use. The Central Government, in consultation with DTAB, may pennit import of any drug or class of drugs not being of standard quality. The Central Government makes ntles in consultation with DTAB for requirements of import licence, list of drugs for which licence is required, methods of analysis, the diseases for which imported drug may not claim cure, prescribe the places of import, conditions and all related matters.
The licence is issued in Form-l0 orl0-A as the case may be. The application for both import licence and Registration Certificate may be made by manufacturer himself or his authorized agent in India having a valid licence. Both the import licence and Registration Certificate are valid for a period of three years from date of issue. If the application is made three months in advance before expiry of licence or certificate, it is valid until orders are passed on application.
Permitted Places for Import of Drugs The import of drug into India is permitted only from following places: Conditions of Import Licence The importer has to fulfil the conditions that are stipulated in the Rules and also comply with following conditions. The manufacturer shall observe undertaking given in Form 9 2. The Licensee should maintain a proper record of imported drug wherein the entries should be made serially for the stock of imported material, its distribution, persons to whom the imported drug is issued, price charged, remaining and quantity of imported drugs.
The drug imported for the purpose of test or analysis or the new drugs imported are not for general use. The importer should maintain all proper storage facilities for drugs imported as required in accordance with the provisions of the Act. The importer should permit the inspector or officer on behalf of the State Government or Central Government without notice to inspect the premises, stocking facilities, records, analytical details, and sale of imported substance.
The licensee should withdraw the substance from market if asked to do so by Authority, iffound that the substance is substandard. An import licence is for one category of drug from single manufacturer abroad, or it could be for more drugs from same manufacturer from one location. Separate licence is required for import of drugs from different manufacturers or from the same manufacturer located at different places.
Other Features of Import. No new homoeopathic medicine can be imported without permission in writing from the LicensingAuthority. Small quantities of a new drug may be permitted for import by a Government hospital or Autonomous medical institution for the treatment of patient suffering from life threatening disease, subject to fulfillment of conditions laid down for the purpose.
Small quantities of drugs for examination, test or analysis may be imported subject to the conditions that the licensee shall use the drug exclusively, for the purpose for which it is imported; the licensee shall allow any inspector authorized by the licensing authority to inspect premises without prior notice and investigate the manner in which substances are being withdrawn and used.
The licence is issued in Form The licensee should maintain all the records and comply with conditions stipulated for licence. However, quantity only upto average doses of such drug is permitted for import. Suspension and Cancellation of Import Licence or Registration Certificate If the manufacturer or licensee fails to comply with any conditions of the Registration Certificate, the licensing cwthority may after giving him an opportunity to show cause may suspend or cancel the Registration Certificate for such period as it thinks fit.
However, the aggrieved person may appeal to the Central Government within thirty days against such order and the decisidn of the Government in this regard shall be final. Offences and Penalties a An offence of any adulterated section 9-A or spurious drug section 9-B or cosmetic section being imported into the country in violation of provisions of the Act is punishable with imprisonment upto three years and a fine upto five thousand rupees b If any drug or cosmetic other than one referred to under a if.
Schedule M GMP Good Manufacturing Practices and Requirements of Premises, Plant and Equipment In order to ensure production of quality drug formulation, it is necessary on the part of the manufacturer to follow well established and ethical approach involving different operations of manufacture. It was on several occasions discussed in professional meetings and conferences that there is a need for well set mandatary guidelines required to be followed by manufactures of different dosage formulations.
The quality of drug formulations is the sole responsibility of the manufacturer. He has to ensure the production of desired quality formulations and their stability until, the formulation reaches the consumer across the retailing counter. The Schedule M is covered under Rules 71, 74, 76 and 78 and is in two parts. Part I deals with GMP relating to factory premises and materials.
Part II deals with requirement of plant and equipment. Warehousing Area. Adequate area for orderly warehousing of various categories of materials; adapted to ensure good storage condition; protection from adverse weather conditions; separate earmarked areas in same warehouse for quarantine status; separate sampling area; segregation for storage of rejected, recalled or returned materials; safe and secure areas for NDPS and hazardous substances; safe storage of printed packaging material; separate dispensing areas for Beta lactum, sex hormones, cytotoxic substances and other special categories; regular checks and rodent control.
Sterile Products. Separate enclosed area with air locks; air supply through HEPA filters; routine microbial counts; laminar flow cabinets availability and access restricted only to authorized persons.
Working Space. Adequate space for orderly placement of equipment and material; and separate storage area for raw material "under test", "approved" and "rejected". The pipe-work, electrical fittings and ventilation openings should be properly designed. The workers should be free from contagious diseases. It covers regular medical check-up facilities; proper toi let faci lity at a distance; personal cupboards and change room for workers. Also, their actions and addiction liability has profound medico-legal implications.
A forensic pharmacologist can help in achieving this vision with the better use of analytical methods to detect the doping and can also help in avoiding accidental use of ergogenic drugs by athletes. Additionally, they can also advise on the drug interactions and use of drugs for therapeutic purposes in athletes.
Blood levels The forensic pharmacologist can assess and analyze the blood samples of a person to determine high and borderline doses, signs of toxicity, lack of therapeutic effect, or a suspected case of poor adherence. The pharmacologist can also closely monitor the narrow therapeutic range of different drugs such as digoxin, lithium, or theophylline. The forensic pharmacologist can interpret the concentration of alcohol in blood and its typical effects.
Pharmacokinetics is employed to measure the blood level of alcohol at the time of the alleged crime. Drug interactions, synergistic or antagonistic effect of different drugs on alcohol absorption or metabolism, and the disease state present in the individual can be easily assessed by the forensic pharmacologist and provide a great help to the medico-legal and judicial system. There are many cases where a forensic pharmacologist can provide a testimonial such as use of drug or poison as a weapon, mental impairment caused due to the effect of a medication, or the use of a specific drug as the reason for criminal aggression.
Drugs are frequently used in suicide attempts and as a tool of homicide or sexual assault. Considering the patient safety, such problems should be reported and scrutinized in detail. Pharmacovigilance is the well-known science related to the adverse effects or any other drug-related problems. Pharmacovigilance can also be used as an important medical discipline in forensic cases in a variety of ways, e.
The teratogenicity with Thalidomide is the classic example.
It differs from Pharmacovigilance as it considers the medico-legal implications as well. Off-label drug use Forensic pharmacologist also plays a significant role in civil cases which involve review of insurance claims. The forensic pharmacologist can testify about the appropriateness and urgency of the unlabeled use of a drug.
Dewan highlighted the importance of teaching regarding prevention, monitoring, evaluation, diagnosis, and treatment of toxic exposures including intentional, unintentional, occupational, and environmental exposures. National blood policy. Pharmaceutical policy The drugs price control order DPCO Forensic Pharmacy is the foundation of the structure on which the sacred profession of Pharmacy has been built up in our country. It provides much needed legal support professional backing and ethical strength for the systematic growth of the profession.
Pharmacist as a drug custodian drug maker drug counsellor drug dispenser drug analyser and drug educator has to discharge his duties within the orbit of professional discipline. The profession derives its strength from the legal provisions such as acts rules bill orders and statutes covered in forensic pharmacy also known as pharmaceutical jurisprudence.
Besides historical developments of drug legislations pharmaceutical ethics and study of allied legislative pieces constitute core of the subject. It was the endeavour of the authors to provide lucid and easily understandable text of the subject for the students of pharmacy based on their long experience of handling the classes in the subject of forensic pharmacy. Bookseller Inventory Ask Seller a Question. Bibliographic Details Title: Textbook of Forensic Pharmacy Publisher: Paperback Book Condition: As New Edition: About this title Synopsis: Hard to find "About this title" may belong to another edition of this title.
Store Description A one stop shop for books from India. We can supply any title published in India by any publisher. We have an extensive annotated catalogue of books on the web. Visit Seller's Storefront Terms of Sale: More Information.Minimum Qualification for Registration as a Pharmacist in India The minimum qualification for registration as a pharmacist in India is a pass in "Diploma course in pharmacy" from an institution recognized by the PCI.
Thanks Admin for create a nice Pharmacy Book Blog. I shall endeavour to discover and manufacture drugs of quality to alleviate sufferings of humanity. Thanks for the share There should be legislations to control drugs and other remedies whether belonging to the B.
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