Key Concepts and Regulations in Pharmacy Practice
1. What is a Schedule X Drug?
Schedule X drugs are controlled substances listed under the Drugs and Cosmetics Rules, 1945. They are known for their potential for abuse and addiction. These include certain sedatives, hypnotics, and other psychotropic substances. They can only be sold with a prescription from a registered medical practitioner and must be labeled with “Schedule X Drug” prominently.
2. What is the Main Objective of Pharmacy?
The main objective of pharmacy is to ensure the safe, effective, and optimal use of medications to improve health outcomes. This includes drug formulation, dispensing, patient education, and the development of pharmaceutical products.
3. Difference Between State Council and Joint State Council
State Council
- Established by a single state under the Pharmacy Act.
- Manages pharmacy registration within one state.
- Independent governance by the respective state.
Joint State Council
- Formed by two or more states for administrative efficiency.
- Oversees pharmacy-related regulations across states that form the council.
- Joint governance by member states.
4. Difference Between Misbranded Drugs and Spurious Drugs
Misbranded Drugs
- Drugs that are improperly labeled or packaged.
- May contain correct ingredients but fail to meet labeling standards.
- Governed under Section 17 of the Drugs and Cosmetics Act.
Spurious Drugs
- Fake or counterfeit drugs intended to deceive consumers.
- Do not contain the declared active ingredients or contain harmful substitutes.
- Governed under Section 17-B of the Drugs and Cosmetics Act.
5. What do Schedule C & H Show in the Drugs & Cosmetics Act?
Schedule C: Lists biological products like vaccines, sera, toxins, and antigens. These require special storage and handling.
Schedule H: Includes prescription-only drugs, which cannot be sold without a prescription from a registered medical practitioner.
6. What is Schedule M?
Schedule M provides guidelines for Good Manufacturing Practices (GMP) for pharmaceutical products. It ensures the quality, safety, and efficacy of drugs. It covers:
- Facility design
- Equipment requirements
- Documentation
- Hygiene and sanitation
For Ascorbic Acid Injection, a diagram would show:
- Vial with label
- Dosage strength (e.g., 500 mg/mL)
- Storage conditions (e.g., “Store below 25°C”)
- Sterility information
7. Qualifications Required for a Drug Inspector
- Education: A degree in Pharmacy, Pharmaceutical Sciences, or Medicine with a specialization in Clinical Pharmacology or Microbiology.
- Experience: Some states require 3-5 years of experience in manufacturing or testing drugs.
8. What is a Register or Sub-register?
- Register: A list of qualified pharmacists maintained by the State Pharmacy Council.
- Sub-register: A supplementary register for temporary registration or specific categories of pharmacists.
9. Penalties Related to Prohibited Advertisement of Drugs
Under the Drugs and Magic Remedies Act, 1954:
- First offense: Imprisonment up to 6 months and/or a fine.
- Subsequent offenses: Imprisonment up to 1 year and/or a higher fine.
10. Definitions of Charas, Ganja, and Cocaine
- Charas: Resin extracted from the cannabis plant.
- Ganja: Flowering or fruiting tops of the cannabis plant, excluding seeds and leaves.
- Cocaine: A powerful stimulant drug derived from coca leaves.
11. Short Note on the NDPS Central Committee
The NDPS (Narcotic Drugs and Psychotropic Substances) Central Committee advises the government on controlling and regulating narcotics and psychotropic substances. It ensures compliance with international treaties and reviews policies.
12. Schedule M for Solid or Parenteral Manufacturing
Solid Dosage Forms:
- Separate areas for granulation, compression, coating, and packaging.
- Controlled humidity and temperature.
- Dust extraction systems.
Parenteral Preparations:
- Sterile production areas with HEPA filters.
- Strict aseptic techniques.
- Regular sterility testing and validation.
13. Offenses and Penalties Related to Illegal Import, Export, or Plant Shipment of NDPS
- Offenses:
- Unlawful possession or transportation.
- Cultivation of narcotic plants without permission.
- Penalties:
- Imprisonment ranging from 10 years to life.
- Fines up to ₹1 lakh or more.
- Seizure of goods and assets related to the offense.
Various Acts Related to Drugs and Pharmacy Profession
- Prevention of Food Adulteration Act, 1954
- Industries (Development and Regulation) Act, 1951
- Industrial Employment (Standing Orders) Act, 1946
- Industrial Disputes Act, 1947
- Factories Act, 1948
- Indian Patents and Designs Act, 1970
- Trade and Merchandise Marks Act, 1958
- Epidemic Diseases Act, 1897
- Shops and Establishments Act (of respective State)
Objectives of the Pharmacy Act, 1948
The Pharmacy Act, 1948 was passed with the following main objectives:
- To make better provisions for regulating the profession and practice of pharmacy.
- To raise the status of the “Profession of Pharmacy” in India.
- To constitute the “Pharmacy Council of India” for setting new standards in pharmacy education.
- To regulate pharmacy institutions, especially “Diploma in Pharmacy,” through education regulations with the registration of pharmacists.
Definitions Under the Pharmacy Act, 1948
- Registered Pharmacist: A person whose name is currently entered in the register of the state in which they reside or carry on their profession or business of pharmacy.
- Central Council: The Pharmacy Council of India (PCI) constituted under section 3 of the Pharmacy Act, 1948.
- Executive Committee: The executive committee of the Central Council or State Council, as the context may require.
- State Council: A “State Council of Pharmacy” constituted under section 19, including a “Joint State Council of Pharmacy” constituted in accordance with an agreement under section 20 of the Pharmacy Act, 1948.
- Displaced Person: Any person who left or was displaced from their place of residence in Pakistan on or after March 1, 1947, due to the setting up of the dominions of India and Pakistan or due to civil disturbance or fear thereof, and has since been residing in India.
- Central Register: The register of pharmacists maintained by the Pharmacy Council of India under section 15A.
Pharmacy Council of India (PCI)
The first Pharmacy Council was constituted in 1949. It is reconstituted every five years. The PCI is constituted under section 3 of the Pharmacy Act, 1948, and consists of the following members:
A. Elected members
B. Nominated Members
C. Ex-officio members
Functions of PCI:
- To regulate pharmacy institutions, especially Diploma in Pharmacy, through education regulation.
- To periodically frame “Education Regulations” with the approval of the central government for setting new standards for pharmacy education.
- To approve or disapprove courses of study and examinations in pharmacy.
- To recognize foreign qualifications in pharmacy for the purpose of registration.
- To maintain the central register of pharmacists.
Drug Technical Advisory Board (DTAB)
DTAB is constituted by the Central Government to advise the Central and State Governments on technical matters arising out of the administration of this Act. It consists of 18 members: 8 ex-officio, 5 nominated, and 5 elected members, as follows:
I. Ex-officio members:
- Director General of Health Services (chairman)
- Drug Controller of India
- Director, Central Drug Laboratory, Kolkata
- Director, Central Research Institute, Kasauli
- Director, Indian Veterinary Research Institute, Izatnagar
- President, Pharmacy Council of India
- President, Medical Council of India
- Director, Central Drug Research Institute, Lucknow
II. Nominated members:
- Two persons nominated by the Central Government from amongst persons who are in charge of drugs control in the states.
- One person from the Pharmaceutical industry, nominated by the Central Government.
- Two Government analysts, nominated by the Central Government.
III. Elected members
- A teacher in Pharmacy or Pharmaceutical Chemistry or Pharmacognosy on the staff of an Indian University or an affiliated College, elected by the Executive Committee of the Pharmacy Council of India.
- A teacher in medicine or therapeutics on the staff of an Indian University or an affiliated college, elected by the Executive Committee of the Medical Council of India.
- One Pharmacologist elected by the Governing body of the Indian Council of Medical Research.
- One Person elected by the Council of the Central Medical Association.
- One Person to be elected by the Council of the Indian Pharmaceutical Association.
Drug Consultative Committee (DCC)
- The Drugs Consultative Committee is constituted by the Central Government. It is an advisory committee for the Central and State governments and the DTAB.
- It consists of two representatives nominated by the Central Government and one nominee of each of the State Governments.
- The Committee meets when required by the Central Government to do so and is empowered to regulate its own procedure.
Central Drug Laboratory
The Act provides for the establishment of a Central Drug Laboratory under the control of a director appointed by the Central Government. This laboratory, established in Kolkata, has been entrusted with the following functions:
- To analyze or test samples of drugs or cosmetics sent to it by the Customs Collectors or Courts.
- To carry out such other duties as entrusted to it by the Central Government or, with its permission, by the State Government after consultation with the DTAB.
The functions of the laboratory in respect of sera, solutions of serum proteins for injection, vaccines, toxins, antigens, antitoxins, sterilized surgical ligature and sutures, and bacteriophages are carried out at the Central Research Institute, Kasauli.
Import of Drugs
Import of drugs without a license:
- Substances not used for medicinal purposes.
- Drugs in Schedule C1 required for manufacturing and not for medicinal use.
- Substances that are both drugs and foods, such as: Condensed/Powdered Milk, Malt, Lactose, Farex/Cereal, Oats, Predigested foods, Ginger, Pepper, Cumin, Cinnamon.
Classes of drugs prohibited to import:
Import of drugs under license:
- Specified in Schedule C/C1.
- Specified in Schedule X.
- Imported for Test/Analysis.
- Imported for personal use.
- Any new drugs.
- Drugs exempted from the provisions of import.
Classes of Cosmetics prohibited to import:
- Misbranded cosmetics.
- Spurious cosmetics.
- Cosmetics containing harmful ingredients.
- Cosmetics not of standard quality.
- Cosmetics containing more than 2 ppm Arsenic, 20 ppm lead, or 100 ppm heavy metals.
Manufacture of Medicinal and Toilet Preparations Containing Alcohol
There are two modes of manufacture:
- Manufacture In-bond
- Manufacture outside bond
- In the first case, alcohol on which duty has not been paid shall be used under excise supervision. In the case of manufacture outside bond, only alcohol on which duties have already been paid shall be used.
1. Manufacture In-bond (Bonded Laboratory)
- Only one entrance and door to every compartment should be provided in the bonded factory.
- If the manufacturing facility is not situated near a distillery or spirit warehouse, one plain spirit store should be arranged.
- A large room should be present to manufacture medicinal preparations, and separate arrangements should be made for manufacturing toilet preparations.
- In the bonded premises, a room with basic furniture should be present for officers in charge.
- Each window should be fitted with flexible iron rods placed four inches apart, with a depth of 2 inches in brick, internally covered with strong wire netting or mesh with a diameter of one inch.
- Outside each room in the manufacturing area, a board should be displayed carrying a specific name and a serial number.
- Each pipe coming from the sink or washbasins in the manufacturing area should be attached to a common drainage system to dispose of all waste.
License for a bonded laboratory:
To manufacture alcoholic preparations and narcotics, an authorized license is needed, which is issued only if the individual already has the license to manufacture drugs as per the Drug and Cosmetic Act and Rules. To obtain the license or to renew it, an application is forwarded to the licensing authority, who may be:
- The Excise Commissioner when the license has to be obtained for a bonded manufacturing facility.
- An officer appointed by the state government when the license has to be obtained for non-bonded manufacturing.
2. Manufacture Outside Bond (Non-bonded Laboratory)
The production of Medicinal and Toilet Preparations can be carried out without bond by the manufacturer after obtaining the respective license. An application for the license in the prescribed form is sent to the officers appointed by the state government for this purpose.
Retail Sale
For retail sales, two types of licenses are issued:
- General
- Restricted
General licenses are granted to persons who have premises for the business and who engage the services of a qualified person to supervise the sale of drugs and do the compounding and dispensing.
Conditions:
- Licenses should be displayed in a prominent place in a part of the premises open to the public.
- The licensee should comply with the provisions of the Drugs and Cosmetics Act and Rules in force.
- Any change in the qualified staff in charge should be reported by the licensee to the licensing authority within one month.
- Any change in the constitution of the licensed firm should be informed to the licensing authority within three months, and in the meantime, a fresh license should be obtained in the name of the firm with the changed constitution.
Restricted licenses:
- Licenses for the restricted sale of drugs other than those specified in Schedule C, C₁, and X, and those specified in Schedule C and C1 but not in Schedule X, are issued in forms 20A and 21A, respectively.
Conditions for Restricted Licenses:
- The licensee must have adequate premises equipped with facilities for the proper storage of drugs to which the license applies, provided that this condition does not apply to vendors.
- The licensee should comply with the provisions of the Drugs and Cosmetics Act and Rules in force.
- Drugs should be purchased only from a duly licensed dealer or manufacturer.
- If the licensee is a vendor having no fixed place of business, they should buy drugs from dealers specified in their license.
- Drugs should be sold in their original containers.
Packing of Drugs
The pack size of drugs meant for retail sale shall be as prescribed in Schedule P1 to the rules and for other drugs as given below:
- Less than 10 Tablets/Capsules: Packing by integral number.
- More than 10 Tablets/Capsules: Multiples of 5.
- Liquid oral preparation: 30ml (pediatric only), 60ml, 100ml, 200ml, or 450ml.
- Pediatric oral drops: 5ml, 10ml, or 15ml.
- Eye/Ear/Nasal drops: 3ml, 5ml, or 10ml.
- Eye ointment: 3g, 5g, or 10g.
Manufacture of Drugs
A person who is interested in starting the manufacturing of drugs is required to fulfill several conditions laid down in the DCA and Rules.
The conditions to be fulfilled before a license is granted are collectively called “Conditions Precedent,” and conditions that are required to be fulfilled after the license is obtained for manufacturing are called “Conditions Subsequent.”
The Licensing Authority is both in the States and at the Central Government. The Central Government is empowered to prohibit the manufacturing and sale of any drug formulation in the public interest.
1. Manufacturing of Drugs for Examination, Test, or Analysis
Conditions:
- The manufactured drugs should be kept in containers bearing an appropriate label indicating the purpose of the test or analysis.
- The drugs should be used for the purpose for which they are manufactured.
- When the material is supplied to another manufacturer, the label stating the name and address of the manufacturer, the scientific name of the drug, the license number, the date of manufacture, etc., should be provided.
- The manufacturer should allow the Inspector to inspect the premises, manufacturing, and analytical records and withdraw samples if required for analysis.
- The manufacturer should comply with the provisions of the Act and Rules.
- The manufacturer should maintain an Inspection Book, and the same should be shown to the Inspector.
- The licensee should comply with other requirements for which a notice has been given to him one month before by the Licensing Authority.
2. Manufacture of a New Drug
A license is obtained from the licensing authority on application in the prescribed form No. 24 A, 27 A with the prescribed fees.
3. Manufacturing Under Loan Licenses
A loan license is given to a person who does not have their own arrangements for manufacturing but wishes to avail the manufacturing facilities owned by another licensee. For drugs other than Schedules C, C(I), and X, loan licenses can be given. An application for a grant or renewal of a loan license is made in Form 24-A. The license is issued by the Licensing Authority in Form 25-A, which is valid for one year.