Note: 66 Glucose Test Reagents/Kits: Medical Devices. Glucose test reagent kits are classified as Class B medical devices under two notified categories ( effective date 01-01-2018 ): 1. Clinical Chemistry (Sr. No. 19 in IVD list): Intended for the estimation of glucose in the body. 2. Self-Testing (Sr. No. 47 in IVD list): Intended for preliminary self-testing of glucose in body fluids. Both categories of these kits are notified under the Medical Device Rules (MDR), 2017 , simultaneously. Manufacturers and regulators of medical devices are requested to take note. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Latest Notifications: Medical Devices Classifications of Medical Devices Guidance documents for industry Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 133 Documents required for new license for Drugs (allopathic) Testing Laboratory

Note: 133 Documents required to be submitted while applying for new license for Drugs (allopathic) Testing Laboratory List of documents: 1. Application 2. Treasury Challan of license fee paid 3. Duly filled Form 36 4. List of Directors 5. Resolution of directors 6. Memorandum of Association & Articles of Association 7. Organization Chart 8. Proof of ownership of premises or rent deed 9. Non conviction affidavit of directors 10. Non conviction affidavit of technical staff 12. Qualification documents of Analytical Chemists/technical persons 13. List of technical staff 14. List of books 15. Pollution NOC 16. Fire NOC 17. Agreement for disposal of biomedical waste 18. List of Instrument 19. Purchase bills of instrument 20. List of SOPs 21. List of STPs 22. Schematic drawing of AHU 23. Blue print 24. Pest control agreement 25. Area validation 26. Medical records of appointed staff 27. NOC from HSIIDC 28. IQ, OQ & PQ of every sophisticated equipment 29. IHS test procedures 30. IPRS procured from IPC and their purchase bills 31.Validation reports 32. Provision for power back-up 33. Experience certificates of technical staff according to their job responsibilities 34. List of categories Must read: Procedure to obtain license for Commercial Testing Laboratories FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 132 Certificate of Pharmaceutical Products (COPPs):

Note: 132 Certificate of Pharmaceutical Products (COPPs): 1. COPPs are issued by SLAs to drug manufacturing firms for allopathic drugs (formulations and bulk). 2. COPPs are also issued for ayurvedic drugs. 3. There is no provision of COPPs for cosmetics and homoeopathic drugs. 3. Power to issue COPPs is a delegated power of the DCGI to SLAs. 4. An NOC from respective Zonal Office of CDSCO is required for issuance of new or additional COPPs. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 131 Checklist for Approval of Technical Personnel

Note: 131 Checklist for Approval of Technical Personnel: Documents required as under: 1. Appointment Letter 2. Joining Letter 3. Experience Certificates 4. Non-Conviction Certificate/Affidavit 5. BPR/Testing Record 6. Salary Records 7. Qualification Certificates. Note: Requirements of some of the documents may vary from state to state. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 130 License in Form 29

Note: 130 License in Form 29 1. As per notification no. GSR 103(E) dated 02.02.2017 by the Government, the Test License in Form 29 (rule 89) under Drugs and Cosmetics Act & Rules is granted for a period of three years. 2. After three years, the license can be renewed annually. 3. A fee of Rs. 250/- is required to be deposited while submitting the application in Form 30 . Must read: Procedure to obtain license for Commercial Testing Laboratories FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 129 Additional Documents Required for Issuance of Form 30 for Ketamine (API and Formulations)

Note: 129 Additional Documents Required for Issuance of Form 30 for Ketamine (API and Formulations) For the issuance of Form 30 to the firm applying for Form 29 for Ketamine (API and formulations), a Schedule X drug under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, the following additional documents and conditions are required: 2. Record Maintenance: The laboratory must maintain records as per NDPS Rules to prevent misuse of Ketamine . 3. Quantity Justification: Provide a detailed justification for the quantity of Ketamine requested, along with restrictions on the approved amount. 3. CBN Registration: Submit valid registration with the Central Bureau of Narcotics (CBN). 4. Exemption under Rule 66: As per Rule 66 of the NDPS Rules, scientific or medical institutions are exempt for research and development purposes. 5. Declaration: Submit a declaration stating that the Ketamine (API/formulations) will be used exclusively for testing, analysis, and examination, and not for commercial purposes. 6. Undertaking: Provide an undertaking confirming that there will be no commercial sale of the substance. Must read: Ketamine: Understanding its Classification and Regulations in India FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 128 Qualifications of technical person under form 29

Note: 128 Qualifications of technical person under form 29 : 1. The Drugs Act does not specify qualifications for a technical person under Form 29. 2. An expert is permitted to develop analytical methods and products. 3. The rules do not mandate specific qualifications or experience. 4. The State Licensing Authority (SLA) may impose qualification conditions as per law. Must read: Procedure to obtain license for Commercial Testing Laboratories FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 127 Veterinary Blood Centers in India

Note: 127 Veterinary Blood Centers in India 1. There is no provision under the Indian Drugs Act for veterinary blood centers. 2. Currently, there are only three veterinary blood banks in India: A. Madras Veterinary College, Chennai (Tamil Nadu) B. Jeevashram Foundation, Rajokri, South West Delhi C. Guru Angad Dev Veterinary and Animal Sciences University (GADVASU), Ludhiana (Punjab) Must read: FAQs on Blood centres FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 126 License in Form 29

Note: 126 License in Form 29 1. As per notification GSR 766(E) dated 27th October, 2021 , issued by the Government, the license in Form 29 under the Drugs Act & Rules must be granted by the Licensing Authority within seven working days of receiving a duly completed application in Form 30 . 2. If the applicant does not receive any communication from the Licensing Authority within the aforementioned seven-day period, the license will be deemed to have been granted by the Licensing Authority. Must read: FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 125 Powder Formulations

Note: 125 Powder Formulations : 1. The category of powders is defined under Schedule M. 2. Separate sections are required to manufacture formulations ie : a. Oral General b. Oral Beta-lactum 3. These formulations should be manufactured in a separate section. 4. They should not be manufactured in capsule sections. 5. Dusting powder should be manufactured in the External Preparation Section. 6. No detailed requirements are mentioned in Schedule M regarding manufacturing of powder formulations. Must read: Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 124 Drug Buprenorphine

Note: 124 Drug Buprenorphine 1. Drug Buprenorphine is notified as a psychotropic substance under the NDPS Act, 1985 . 2. Its definition is given in Section 2(xxiii) of the NDPS Act. 3. It is also notified as a Schedule H1 drug . 4. A valid drug sale license is required to sell Buprenorphine. 5. Buprenorphine is available in both injectable and tablet forms in the Indian market. 6. The sale of psychotropic drugs is governed by the rules 64 to 67 of the NDPS Rules. 7. The small quantity limit for Buprenorphine is one gram, and it is listed at sr. No. 169 of NDPS list. 8. Its commercial quantity limit is 20 grams . 9. 'NRx' must be printed on the top left corner of the label of the drug. 10. Stocking Buprenorphine without a valid drug sale license is a violation of Section 8 and Rules 64 & 67 of the NDPS Act and is punishable under Section 22 of the Act. 11. Registration with Narcotics Control Bureau (NCB) and online submission of reports is mandatory for manufacturers of Buprenorphine. 12. As per orders of DCGI, CDSCO, and New Delhi, the sale of FDC of Buprenorphine + Naloxone in sublingual tablets dosage form is restpsychiatric clinics, hospitals and de-addiction centres only. Must read: FAQs on NDPS (Narcotic Drugs) FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 123 Ear Drops: 1. Technically, ear drops are classified as the External Preparations which are for 'external use' only. 2. Ear drops are not to be injected directly into the bloodstream. 3. When surgical intervention is required, sterilized products should be used. 4. According to the Indian Pharmacopoeia (IP), ear drops are non-sterile products. 5. Non-sterile ear drops should not be manufactured in the area/section used for manufacturing injectables. 6. Sterile ear drops must be manufactured under the manufacturing conditions and labeling provisions specified for sterilized products. 7. However , a separate category for ear drops is not mentioned in Schedule M, but under the External Preparation category, it is specified that a separate area must be provided for manufacturing the products meant for internal use. 8. As per Rule 105 of the Drugs Rules, pack size for ear drops must be be 3ml, 5ml, and 10 ml only. 9. As some drop formulations are intended to be used as both eye drops and ear drops , they should be sterilized formulations and should be manufactured in the sterilized injectable area of the manufacturing facility. 10. As per Rule 97(xi) of the Drugs and Cosmetics Rules, ear drops are exempted from the requirement of Schedule H warning on the label, but as per Note 2 of the Schedule, the antibiotic and steroid ear drops are not exempted from the provision of Rule 97(xi). Must read: FAQs – on Ear Drops FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 122 Class A Non-Sterile and Non-Measuring Medical Devices

Note: 122 Class A Non-Sterile and Non-Measuring Medical Devices: 1. As per G.S.R. 777(E), dated October 14, 2022 , Class A Non-Sterile and Non-Measuring Medical Devices have been exempted from the licensing regime. 2. Only registration on 'Online System for Medical Devices' ' www.cdscomdonline.gov.in ' is required for manufacturing of Class A Non-Sterile and Non-Measuring Medical Devices. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 121 Steroid hormones are mainly classified into two groups

Note: 121 Steroid hormones are mainly classified into two groups: 1. Corticosteroid - examples: Dexamethasone, Betamethasone, etc. 2. Corticosteroids are manufactured in a facility licensed under Form 25 , where other drugs are also manufactured. 3. Sex Hormones - male, female hormones. 4. A dedicated manufacturing facility, licensed under Form 28 , is required for the manufacturing of sex hormones. 5. The manufacturing area must be separate for male hormones and female hormones. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 120 Labeling of API with QR code

Note: 120 Labeling of API with QR code As per the amendment in rule 96(5) of the Drugs Rules, 1945 vide notification G.S.R. 20(E) dated 18th January, 2022 , a QR (Quick Response) code must be printed on the label of every Active Pharmaceutical Ingredient (API). This notification has been in effect since 01.01.2023 . Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 119 Hemodialysis Concentrate

Note: 119 Hemodialysis Concentrate : Medical Devices : Class C Use: Intended to remove metabolic waste from the blood and help maintain physiological blood electrolyte and pH levels during hemodialysis. 2. Before MDR 2017 , this product was non-sterile and was permitted under Form 25 by the SLA. 3. Now, under MDR 2017 , this product is classified as a Class C medical device, and a license will be granted by the DCGI office. 4. It is possible that some manufacturers are unaware of this change and may still be producing this product under Form 25 . Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 118 Rule 45(1) of the Drugs Rules 1945: Test reports

Note: 118 Rule 45(1) of the Drugs Rules 1945: Test reports According to notification number GSR 103(E) dated 02.02.2017 , the Government Analyst must furnish reports of the results of tests or analysis of drug samples within sixty days of receipt of the sample by the Government Analyst from the Drugs Inspector or other person under provisions of the Act. If it is not possible to give a test report within the specified period, the Government Analyst must seek an extension of time from the Government giving specific reasons for the delay. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 117 Stop Manufacturing Activities & Stop Testing Activities

Note: 117 Stop Manufacturing Activities & Stop Testing Activities 1. Rule 85 of the Drugs Rules vests the Licensing Authority with power to issue an order to drugs manufacturing firms to stop manufacturing activities of allopathic drug(s) for a valid reason. 2. Whereas, Rule 150K of the Drugs Rules empowers the licensing authority to withdraw the approval or suspend approval wholly or partially of an approved institution for a valid reason. There is no provision to stop testing activities in this rule. 3. It means the State Licensing Authority (SLA) cannot issue an order to stop testing activities of an approved institution or drug testing laboratory. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 116 Test Reports Issued to Government Health Institutions by Private Labs :

Note: 116 Test Reports Issued to Government Health Institutions by Private Labs : Notification: 223(E) dated 19 March 19, 2019 As per this notification, private labs must issue test reports for samples received from government institutions using Form 39A. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 115 Tramadol/Tapentadol: Labeling

Note: 115 Tramadol/Tapentadol: Labeling. 1. The labels of the drugs Tramadol and Tapentadol must include a statement indicating the use of these drugs by adults in acute pain only. 2. It should also be noted that these drugs should not be used for more than five days, as it may cause respiratory depression in patients. 3. A letter regarding this matter was issued by the DCGI, New Delhi. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 114 Status of Gentamicin Drug

Note: 114 Status of Gentamicin Drug 1. Drug gentamicin is an antibiotic. 2. It's not a beta-lactam antibiotic. 3. Gentamicin should be manufactured in the General Section Manufacturing Facility. 4. Gentamicin is manufactured under the license granted on Form 28. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 113 Hon’ble Supreme Court: 03.12.2018 (On NDPS)

Note: 113 Hon’ble Supreme Court: 03.12.2018 (On NDPS) 1. The State of Punjab appealed to the Hon’ble Supreme Court against the order of the Punjab & Haryana High Court dated 29.01.2018 in NDPS matters. 2. Case Title: State of Punjab vs. Rakesh Kumar & 26 Others 3. Points Raised by the State of Punjab (Appellant): i) The NDPS Act does not bar the application of the Drugs & Cosmetics Act, 1940. ii) Inderjit Singh vs. State of Punjab (2014, HC). iii) Union of India vs. Sanjeev Deshpande (2014, SC) – This judgment clarified that narcotic and psychotropic substances are permissible only for medical and scientific purposes. 4. Points Raised by the Accused: i) If a person manufactures or deals in NDPS drugs in bulk without a license, the offense falls under the NDPS Act, 1985. 5. Findings of the Hon’ble Supreme Court: i) Section 80 of the NDPS Act clearly states that the application of the Drugs & Cosmetics Act is not barred. ii) The provisions of the NDPS Act do not override the Drugs & Cosmetics Act. iii) The Drugs & Cosmetics Act regulates various aspects of drug manufacture, sale, and purchase, whereas the NDPS Act specifically deals with a certain class of drugs. Therefore, the NDPS Act is a special law on the subject. iv) The NDPS Act should not be read in isolation from the Drugs & Cosmetics Act, 1940. Additionally, it is the state’s authority to prosecute offenders in accordance with the law. v) In the present case, since the accused’s actions prima facie violated Section 8 of the NDPS Act, they were charged under Section 22 of the NDPS Act. 6. Final Decision: The order passed by the Hon’ble High Court is hereby set aside. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 112 Color of test reports

Note: 112 Color of Test Reports: 1. Certificates of test or analysis / Test Reports of a drug sample are issued by the State Drugs Testing Laboratory / Government Analyst on Form-13 and by the Central Drugs Testing Laboratory on Form-2 . 2. White paper is used to issue test reports on Form-13 . 3. Pink paper is used to issue test reports on Form-2 . 3. Although the Drugs & Cosmetics Act and Rules do not mandate any color for the paper used to issue test reports, pink paper is used by the department to issue test reports on Form-2 to differentiate them from Form-13 as per departmental SOPs. Must read: Forms: All types of Drugs FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 111 Gelatin: 1. Gelatin is used in many industries, such as food industry, pharmaceutical industry, cosmetics industry, nutraceutical industry, etc. 2. In the pharmaceutical industry gelatin is used as an ingredient in drug formulations like tablets, capsules, and drug coatings. 3. As per Section 3(b) of the Drugs Act, an empty gelatin capsule is a component of drugs; hence, it falls under the definition of a drug. 4. Consequently, only IP (Indian Pharmacopeial) grade gelatin should be used in allopathic drugs. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 110 Excipients: Status

Note: 110 Excipients: Status 1. Excipients fall under the definition of drugs. 2. Stability data is needed for approval. 3. Category of raw material. 4. The firm should follow Schedule M to manufacture Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 109 Different Types of Alcohol Used in Various Products

Note: 109 Different Types of Alcohol Used in Various Products: Cosmetics : Denatured Alcohol (DNA) External drugs : Denatured Alcohol (DNA) Medical devices : Denatured Alcohol (DNA) Homeopathic medicines : Extra Neutral Alcohol (ENA) Oral drugs : Extra Neutral Alcohol (ENA) or Absolute Alcohol Injections : Absolute Alcohol Must read: FAQs – on Alcohol (in Pharma Industry) The Effectiveness of 70% Alcohol as a Disinfectant FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 108 Retention Samples: (As per the Revised Schedule-M)

Note: 108 Retention Samples: (As per the Revised Schedule-M) 1. Retention samples of finished products should be kept for at least one year after their date of expiry. 2. Samples of active starting material should be retained for at least one year beyond the expiry date of the corresponding finished product. 3. Samples of other starting materials (excluding solvents, gases and water) should be retained for a minimum of two years , provided their stability allows it. 4. Retention samples (starting material and products) should be retained in a quantity sufficient for at least two full re-examinations. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Note: 107 Atezolizumab Drug

Note: 107 Atezolizumab Drug: 1. This drug is used for monoclonal antibody therapy. 2. It may be used in anti-cancer therapy. 3. This drug is not categorized as a ' cytotoxic drug '. 4. Atezolizumab can be manufactured in the General Section of a valid Drug Manufacturing Facility. 5. A separate manufacturing area, as required for manufacturing ' cytotoxic drugs ' is not required for manufacturing Atezolizumab. Must read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit. Kr. Goel Deputy State Drugs Controller FDA Haryana

Important short notes for Industry and Regulators

Q: Note: 156 Schedule P

Note: 156 Schedule P : 1. Schedule P mentioned the expiry dates for different drugs. 2. Manufacturers can decrease the expiry date of their drug based on stability data. However, the expiry date can not be increased. 3. If the expiry date of a drug is not specified in Schedule P, it should be assigned based on conducted stability studies, but up to a maximum of 60 months. 4. For drugs without specified storage conditions in Schedule P, storage at room temperature is recommended. M ust read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Q: Note: 155 Paracetamol + Tolperisone Tablets

Note: 155 Paracetamol + Tolperisone Tablets 1. This drug can be manufactured by all manufacturers, as it is not classified as a new drug. 2. The manufacturer must label the product with the following indication: “For the symptomatic treatment of post-stroke spasticity associated with pain in adults.” M ust read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Q: Note: 154 Glimepiride and Metformin HCL Tablets

Note: 154 Glimepiride and Metformin HCL Tablets: Glimepiride 1mg and Metformin Hydrochloride 500mg Prolonged-release Tablets IP. 1. This drug combination is official in IP 2022. 2. This drug combination is not banned. 3.The combination Glimepiride 1mg and Metformin Hydrochloride 500mg Tablets is irrational/Banned vide DCGI office Letter dated 11 April 2025 . M ust read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Q: Note: 153 Veterinary Drugs

Note: 153 Veterinary Drugs: 1. Veterinary drugs are manufactured in the same areas or facilities where human drugs are produced. 2. But to be provided with proper strict segregation and regulatory standards. 3. Veterinary drugs must be stored separately in chemist shops. M ust read: FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Q: Note: 151 For permission of additional items

Note: 151 For permission of additional items: 1. In notification no. GSR 122(E) dated 17.08.1988, the term ' IP ' was included in the definition of new drug, which meant drugs official in Indian Pharmacopeia (IP) could be allowed for grant of permission. 2. However, on November 07, 2013, the term ' IP ' was removed from the definition of a new drug. 3. Consequently, IP 2010 can be considered for permissions for manufacturing additional drug items by the SLA. 3. IP 2014, IP 2018, and IP 2022 can not be considered for permissions for manufacturing additional drug items by the SLA. M ust read: Fee structure: All types of drugs licenses FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Q: Note: 150 Fee for License on Form 25 and Form 28

Note: 150 Fee for License on Form 25 and Form 28 1. The government of India has replaced the term 'renewal' of licenses with 'retention' of licenses vide Notification no. GSR.1337(E) dated 27.10.2017 . 2. License fee for Form 25 under rule 69(2)(c) of the Drugs Act and Rules is Rs. 7500/- (Rs. 6000 license fee + Rs. 1500 inspection fee). 3. The retention fee for one Form (25) is ₹ 6000, which must be deposited before the expiry of the license. 4. As per Rule 69(2)(c)(iii) of the Drugs and Cosmetics Act and Rules, a fine of 2% is imposed if the retention fee is not submitted before the expiry of the license. 5. In the case of a renewal application, the form and fee must be submitted to the office of the SLA. In case of retention, the fee must be deposited. M ust read: Fee structure: All types of drugs licenses FAQs by Lalit Kr. Goel, DSDC FDA Haryana Important short notes for Industry and Regulators Key Notes on Revised Schedule M: Compilation Guidance documents for industry Lalit Kr. Goel Deputy State Drugs Controller FDA Haryana

Important short notes for Industry and Regulators (Pharmaceuticals, Medical Devices, Cosmetics, Homoeopathy, Blood Centres etc.)

Lalit Kr. Goel

November 3, 2024

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Important short notes for Industry and Regulators

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Lalit Kr. Goel

State Drugs Controller |
Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com

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Last Updated on August 27, 2025 by The Health Master

Important short notes for Regulators and Industry (Pharmaceuticals, Medical Devices, Cosmetics, Homoeopathy, Blood Centres and Repacking etc.)

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Note: 156 Schedule P

Note: 156

Schedule P :

1. Schedule P mentioned the expiry dates for different drugs.

2. Manufacturers can decrease the expiry date of their drug based on stability data.
However, the expiry date can not be increased.

3. If the expiry date of a drug is not specified in Schedule P, it should be assigned based on conducted stability studies, but up to a maximum of 60 months.

4. For drugs without specified storage conditions in Schedule P, storage at room temperature is recommended.

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