'drugs controller general'

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Introduction The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. The Department of AYUSH has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject. On approval of the concept, the Department of AYUSH signed an agreement with the QCI on 27 July 2009 to design the Scheme with Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme. The draft Scheme was given to the Department of AYUSH on 3 Aug 2009 and Simultaneously placed on the websites of Department of AYUSH and QCI for public consultation. The Scheme will be overseen by a Multi stakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI. The Scheme is based on a criteria for certification. It has two levels: Ayush Standard Mark which is based on compliance to the domestic regulatory requirements Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria. Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body.

Apply For USFDA Certification In Indore Looking for comprehensive certification solutions? Shark Certification offers a wide range of services, including FSSC, BRC, HALAL, KOSHER, NGMO, GMP, USFDA, and ORGANIC. Let us guide you through the process. About the U.S. FDA The U.S. Food and Drug Administration (FDA) is a key federal agency under the United States Department of Health and Human Services. As part of the federal executive structure, the FDA plays a vital role in safeguarding public health by regulating a wide range of products including pharmaceuticals, food items, cosmetics, and medical devices. The FDA is responsible for the approval and oversight of: New pharmaceutical products, including biologics Food and feed additives for humans and animals Color additives used in consumables and cosmetics Select categories of medical equipment and devices To ensure that products entering the U.S. market meet stringent quality and safety standards, the FDA also conducts inspections in manufacturing units located outside the U.S., including facilities in India that export drugs and food items to the American market. These inspections are based on Current Good Manufacturing Practices (CGMP) standards set by the agency. Compliance and FDA Inspections During inspections, FDA officials assess the level of compliance with CGMP guidelines. If any deviations or concerns are observed, they are documented in Form 483. This form outlines specific areas of non-compliance and is discussed directly with the management team of the manufacturing facility. Alongside the Form 483, the agency provides an Establishment Inspection Report (EIR), indicating whether any further action is necessary. Companies are expected to respond to the Form 483 within 15 working days. While the response is not legally required, submitting a detailed reply outlining corrective actions is highly recommended to avoid escalation. If the response is inadequate or if violations are severe, the FDA may issue a Warning Letter. In critical cases, enforcement actions such as import alerts, product approval delays, or even revocation of manufacturing licenses can follow. The FDA Approval Process For a drug or high-risk medical device to receive FDA approval, the manufacturer must demonstrate that it is both safe and effective for its intended use. While the FDA itself does not conduct testing, it rigorously reviews the data and clinical trial results submitted by manufacturers. Approval is granted only after a thorough review by a multidisciplinary team of FDA experts—including statisticians, biologists, chemists, and clinicians. Why FDA Compliance Matters for Indian Manufacturers The U.S. remains one of the largest and most lucrative markets for pharmaceutical products. Over the past few decades, Indian pharmaceutical firms have gained a significant presence in the U.S. generics space. To maintain and grow this market share, ongoing compliance with FDA regulations is crucial. Shark Certification Pvt. Ltd. – Your FDA Compliance Partner At Shark Certification Pvt. Ltd., we specialize in helping pharmaceutical and medical device companies navigate the complex regulatory landscape of the U.S. FDA. Our goal is to provide tailored, efficient, and value-driven solutions that reduce compliance risks and enhance operational excellence. Our team comprises seasoned professionals with deep experience in FDA regulations, global quality standards, and risk-based auditing approaches. We support clients from audit readiness to submission preparation—ensuring both compliance and business continuity. Our Core Services CGMP and Pre-Inspection Audits Pre-Approval Inspection (PAI) Preparation Quality Assurance and Control System Development 21 CFR Part 11 & GAMP 5 Compliance & Audit Support IT System Validation and Audit Services Quality Risk Management System Development Process Analytical Technology (PAT) & Quality by Design (QbD) Process Validation and Documentation USFDA Audit Readiness Training Regulatory Submission Support: 510(k), PMA, NDA, ANDA, IND, IDE, DMF, PAS Specialized Expertise Areas End-to-end Quality System Implementation & Gap Analysis Data Integrity & Compliance Audits Vendor and Third-Party Audits Good Clinical Practice (GCP) Audits Risk Assessments and Due Diligence Reviews FDA Form 483 and Warning Letter Responses GMP Compliance for Pharmaceuticals and Medical Devices Partner with Shark Certification Pvt. Ltd. With an unwavering focus on regulatory excellence and global health standards, Shark Certification Pvt. Ltd. is your trusted partner for U.S. FDA compliance. Whether you're preparing for your first inspection or responding to regulatory observations, we provide the guidance, expertise, and support needed to achieve and sustain compliance.

What are the aims and objectives of NABL…? National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide government, industry and society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for testing and calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. What Is Laboratory Accreditation? The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the government in reducing trade barriers and providing greater thrust to exports that makes it imperative for accredited laboratories to be at international level of competence. What Are Benefits Of Accreditation? Potential increase in business due to enhanced customer confidence and satisfaction. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of accredited laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. What types of laboratories can seek accreditation…? The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to: Laboratories undertaking any sort of testing or calibration in the specified fields, private or government laboratories, small operations to large multi-field laboratories, site facilities, temporary field operations and mobile laboratories.

Small Scale and ancillary units (i.e. undertaking with investment in plant and machinery of less than Rs. 10 million) should seek registration with the Director of Industries of the concerned State Government. What Is The Benefit Of Registering With SSI? The registration scheme has no statutory basis. Units would normally get registered to avail some benefits, incentives or support given either by the central or state government. The regime of incentives offered by the centre generally contains the following : Credit prescription (Priority sector lending), differential rates of interest etc Excise Exemption Scheme Exemption under Direct Tax Laws Statutory support such as reservation and the Interest on Delayed Payments Act States/UTs have their own package of facilities and incentives for small scale. They relate to development of industrial estates, tax subsidies, power tariff subsidies, capital investment subsidies and other support. Both the centre and the state, whether under law or otherwise, target their incentives and support packages generally to units registered with them. What Are The Objective Of Registration Scheme Of SSI? They are summarized as follows : To enumerate and maintain a roll of small industries to which the package of incentives and support are targeted. To provide a certificate enabling the units to avail statutory benefits mainly in terms of protection. To serve the purpose of collection of statistics. To create nodal centers at the Centre, State and District levels to promote SSI What Are The Features Of Scheme in SSI? Features Of The Scheme Are As Follows : DIC is the primary registering centre Registration is voluntary and not compulsory Two types of registration are done in all States. First, a provisional registration certificate is given. And after that, commencement of production, a permanent registration certificate is given. PRC is normally valid for 5 years and permanent registration is given in perpetuity. What is Provisional Registration Certificate (PRC)? This is given for the pre-operative period and enables the units to obtain the term loans and working capital from financial institutions/banks under priority sector lending. Obtain facilities for accommodation, land, other approvals etc. Obtain various necessary NOC’s and clearances from regulatory bodies such as Pollution Control Board, Labour Regulations etc. Permanent Registration Certificate Enables The Unit To Get The Following Incentives/Concessions Income-Tax exemption and Sales Tax exemption as per State Govt. Policy Incentives and concessions in power tariff.Price and purchase preference for goods produced Availability of raw material depending on existing policy Permanent registration of tiny units should be renewed after 5 years What is Procedure for Registration of SSI? Features of the present procedures are as follows : A unit can apply for PRC for any item that does not require industrial license which means items listed in Schedule-III and items not listed in Schedule-I or Schedule-II of the licensing exemption notification. Units employing less than 50/100 workers with/without power can apply for registration even for those items that are included in Schedule-II. Unit applies for PRC in prescribed application form. No field enquiry is done and PRC is issued. PRC is valid for five years. If the entrepreneur is unable to set up the unit in this period, he can apply afresh at the end of five years period. Once the unit commences production; it has to apply for permanent registration on the prescribed form. The Following Form Basis Of Evaluation The unit has obtained all necessary clearances whether statutory or administrative. E.g. drug license under drug control order, NOC from Pollution Control Board, if required etc. Unit does not violate any location restrictions in force, at the time of evaluation. Value of plant and machinery is within prescribed limits. Unit is not owned, controlled or subsidiary of any other industrial undertaking as per notification. What Is Requirement For Application Of SSI? Detail Of Application Form As Per Below : Applicant’s name & address Company/Industries name & address Name of products/Item Coast of Machineries

Testing & Calibration Laboratories Quality Management System Consultancy ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO/IEC 17025 : 2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025 : 2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. ISO/IEC 17025 : 2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025 : 2005 is not intended to be used as the basis for certification of laboratories. Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025 : 2005.

Promoting organic production standards to meet consumer demand BUSINESS CHALLENGE Increased cases of unsafe food due to over use of chemical fertilizers and chemicals in food production system, has created an increasing worldwide demand for organic food. The challenge facing the organic agriculture industry is to produce foodstuffs and agricultural products using methods, which respect the environment and animal welfare. Globally, these demands are defined by regulations, particularly in those countries, which consume organic products. The principal standards are NPOP standard (India Organic- APEDA), EU Regulation 834/2007 and the US National Organic Program (NOP). To take into account the regulations in place, the certification scheme depends both on the country of production and the country of destination. This certification is aimed at producer organizations or members of food industries who want to commercialize organic products for a particular market. The organic certification considered as a guarantee of quality and safety by the consumers. What is Organic Certification? Organic certification is a nationally and internationally recognized set of standards aimed at proving that agricultural and food products have been produced without the use of synthetic chemical products, while using methods, which respect the environment and animal welfare. Organic requirements involve a set of production specifications for growing, storage, processing, packaging and shipping. All organic assessment and qualification references require control and certification by an accredited independent body. Organic Certification Requirements vary from country to country and generally involve a set of production standards for growing, storage, processing, packaging and shipping that include: avoidance of synthetic chemical inputs (e.g. fertilizer, pesticides, antibiotics, food additives), irradiation, and the use of sewage sludge; avoidance of genetically modified seed; use of farmland that has been free from prohibited chemical inputs for a number of years (often, three or more); for livestock, adhering to specific requirements for feed, housing, and breeding; keeping detailed written production and sales records (audit trail); maintaining strict physical separation of organic products from non-certified products; Undergoing periodic on-site inspections. Certified organic foods are not necessarily pesticide-free, certain pesticides are allowed. What are the key benefits? Demonstrate Organic Standards compliance of products to clients (retailers, traders, importers) Inspire consumer confidence Ensure greater access to existing and target markets Help protect the environment from harmful products and processes Preserve animal welfare WHY CHOOSE SCPL We are working with USOCA that is accredited for certification according to the NPOP, Swiss, European and NOP (USDA) organic production standard. With the NPOP, the client will also get certificate for Swiss and European Organic certification (EU Regulation No. 834/2007), which will make it recognized by all European Union member countries. In order to access the US market, you have to certify your products to the National Organic Program (NOP).