september 14,singapore · • otc and ethical drugs • advertising and promotion • packaging and...

September 14,Singapore

Dr. Milind AntaniHead, Pharma & Life Science Practice

© Nishith Desai Associates www.nishithdesai.com

http://www.asianpharmacongress.com/index.html

Overview

• Various Drug Laws…..General

• Various Drug Laws…..Specific

• Medical Devices/Equipments– Regulatory Procedural Requirements– Import Procedure– Recent Developments

• Take Away & Experience Sharing

2© Nishith Desai Associates

Various Drug Laws…..General


Various Drug Laws


Laws

Various regulatory aspects related to import, manufacture, sale and advertisements related to drugs are covered under three separate enactments, namely,

• Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules 1945, • The Pharmacy Act, 1948 and • The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954.

–Other guidelines / Acts–Agencies/Authorities

5

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Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules, 1945

The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and conform to prescribed quality standards and the cosmetics marketed are safe for use.Scope

•Approval of New Drugs•Import of new drugs•Manufacturing of New drugs•License to Market•Clinical Trials in the country •Laying down the standards for Drugs •Control over the quality of imported Drugs •Prohibition –

Misbranded, Adulterated, Spurious Drugs and Cosmetics50 Forms40 Schedules The Drugs Controller General of India (“DCGI”) is the apex statutory,

executive and quasi-judicial body at the Central level under the Act and the Rules.

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7

Approval Process ( New Drug )

Dug Approval

Manufacture Sale and Distribution Import of New Drug Clinical Trial

Rules: 122 BSchedule M

Form 44

Rules: Rule 59 Form No: 19

Rules: 122-AForms: 44 and 9

Schedule Y :Good Clinical Practices

Form 44

Foreign Company Domestic Agent

DCGI

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Amended checklist for test license applications effective from 15 June 2011

Various Drug Laws…Specific


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Manufacturing• License to Manufacture Drugs• Industrial Licensing • GMP• Other important approvals / licenses

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Marketing and Distribution

• Licensing of sales outlets/ stocking points,

• OTC and ethical drugs

• Advertising and promotion

• Packaging and labeling

• Distribution methods

• Brand names

• Restrictive trade practices

• Consumer protection• The Shops and Establishment Act

•The Standard Of Weights And Measures Act

• Labor legislation

• Sales tax

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Clinical Trials

• Rules 122 DA to 122 E of Drugs and Cosmetic Rules read along with Drugs and Cosmetics Act

• Rule 122 DAA: defines the term “Clinical Trial”

a systematic study of new drug(s)human subject(s) safety and/or efficacy of the new drug.”

• Rule 122 E New Drug

not been used in the country to any significant extentnot been recognized as effective and safe

• Schedule

Y

to the Rules: Good Clinical Practices • ICMR Guidelines

• ICH Guidelines

• Schedule Y1

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Health Care –

Hospitals / Labs etc..

• Private Hospitals

• Corporate Hospitals

• Diagnostic Laboratories

• Diagnostic Clinics

• Blood Banks

• Radiotherapy Centers etc– All general approvals

– Approval under PNDT Act

– Disposal of Biomedical waste

– Specific approval for Blood banks

– Permissions from BARC

– Other local approvals

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Non-complianceNon-compliance of the following under Drugs Act and Rules norms can trigger cancellation of License

Data Integrity and Reporting: It is important that the data that is submitted by the sponsors and upon which regulators rely, must be complete and accurate as per the requirements of DC Rules.

• Procuring a Proper License: DC Act mandates that the clinical research has to be conducted according to the conditions specified in license and thus conducting clinical research not authorised by the license would attract penal consequences.

• Importing and Manufacturing Permissions:Rule 122-A provides that no drug could be imported or manufactured for a clinical trial without obtaining a proper license. Thus it is important that a valid license should be obtained in order to produce or import right medicine so as to avoid any liability.

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Non-compliance

• Absence of Informed ConsentIf consent of the Subject is procured by coercion, undue influence or inducement, or intimidation , the Investigator may be held liable.

• Breach of ProtocolSchedule Y mandates that the Protocol should describe how protocol violations will be treated, including conditions where the study

will be terminated for non-compliance with the protocol.

Medical Devices /Equipments


Devices/Equipments


Notified Medical Devices


Notified Medical Devices….clarification

• Spinal Needles• Insulin Syringes• Three Way Stop Cock as an accessory

of I.V.Cannula/Catheter/Perfusion Set

• Endotracheal tubes• Introducer Sheath• Annuloplasty Ring• Cardiac Patch• Cochlear Implant • Extension Tube• Close Wound Drainage Set• Trachestomy Tube with / without

Cuff

• AV Fistula Needle• Extension Line as a accessory of

Infusion Set• ANGO kit/PTCA/Cath Lab Kit• Heart Lung Pack• Measure Volume Set• Flow Regulator as a accessory of

Infusion Set• Hemodialysis Tubing Set / Blood

Tubing Set/Arterial Venous Tubing Set

• Dialysis Catheter

Clarification with regard to control of various medical devices (dated : 20.03.2009)


Drug

Sec 3 (b) (iv) of the Drugs & Cosmetic Act.

“

such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification

in the Official Gazette, after consultation with

the Board ”


Regulatory Procedural Requirements


Modes of BusinessImport Of Medical Devices

• For the purpose of import of the regulated devices, the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules, 1945 are to be followed. The license to import will have to be obtained by the importer and not the manufacturer.

Manufacture of medical devices in the country

• An application for the grant of licence is required to be made in a stipulated form to the State Licensing Authority, accompanied by

the requisite fee in the form and manner as prescribed in the Rules,

along with a copy marked to the office of the DCGI.

Sale of medical devices in the country

• The importers, stockiest and retail sellers of the specified devices will be required to obtain appropriate sale licences from the State Licensing Authorities.


Regulatory Requirements

Licenses & Approvals:•

License to sell, stock, exhibit or offer for sale or distribute drugs (Wholesale License)

•

Registration Certificate for the medical device •

Import License


Regulatory ProcedureImport License

Formality• Application under Form 40 to be filed for the grant of Registration

Certificate

in respect of the premises and the devices manufactured by the manufacturer and meant for import.

• An application in Form 8

to be filed for license to import drugs into India. There are associated registration fees.

• The copies of Whole Sale Drug Licence on Form 20-B and 21-B issued by the respective State Licensing Authority (SLA) should be submitted alongwith the application for the purpose of import registration.



The information and documents required to be submitted• Details of the standards followed by the manufacturer for good

manufacturing practices and product evaluation. • Details pertaining to the qualitative and quantitative

particulars of the constituents of such medical devices.

• Brief description of the method of manufacture and specifications of the materials used and information on the stability of such medical devices.

• List of accessories

and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.

• Details of standards to which the device conform along with the copy of the standard.



Regulatory Status:• Approval of the product from any other regulatory agency (Separate

evidence for the approval from the each agency)• US FDA clearance/approval.• EU medical device directive (CE Certificate).• Australia/Canada/Japan approval.• Approval

in any other country. – Copy of ISO/EN Certification if any for the manufacturing facility.– List of countries where the device is being sold.– List of countries where device is withdrawn from sale with reasons, if any.


Regulatory Procedure


Import Procedure


Import Procedure

• Importer and Exporter Code (“IEC”) Number from the office of the Director General of Foreign Trade (“DGFT”).

• The IEC Number would be required to be mentioned in the documents filed with Customs for clearance of imported goods.

• Clearance is usually undertaken by the Customs House Agent (“CHA”) who can be appointed for this task. The duty would be required to be paid, within 5 days.

• All medical equipments (with some exceptions) will attract 5% basic customs duty, 4% CVD/excise duty and Nil special additional duty of customs [i.e. effective duty of 9.2%].


Medical Devices..Recent Developments


Recent Developments

1.

Guidance document on application for grant of Licence in Form-28 for manufacture

of Medical Devices in India

under Central Licensing Approval Authority (CLAA) Scheme;

2.

Guidance Document on Common Submission Format for Registration

of Medical Devices in India;

3.

Guidance Document on Common Submission Format for Import Licence

in Form 10 of Medical Devices in India;

4.

Requirements for Conducting Clinical Trial(s) of Medical Devices in India.


The Medical Devices Regulation Bill, 2006

• Establishment of Medical Device Regulatory Authority Of India (MDRA)• Classification of medical devices• Medical device standards• Conformity assessment and placing on the market• Import of medical devices• Refurbished and date expired medical devices• Vigilance by MDRA• Enforcement • Medical device safety appellate tribunal• Offences and penalties


Take Away & Experience Sharing


Take Aways


Thank You [email protected]

september 14,singapore · • otc and ethical drugs • advertising and promotion • packaging and...

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