'ban drug celestin'

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

Promoting Sustainable, Traceable, and Non-GMO Agriculture with ProTerra Certification By Shark Certification Pvt. Ltd., Indore At Shark Certification Pvt. Ltd., we are proud to offer ProTerra Certification, a globally respected standard for sustainable, non-GMO agriculture and food systems. Designed to ensure transparency, traceability, and ethical practices across the entire supply chain, ProTerra Certification helps organizations demonstrate their commitment to responsible production and environmental stewardship. What is ProTerra Certification? ProTerra is a comprehensive sustainability standard focused on promoting responsible agricultural practices, protection of natural resources, and the exclusion of genetically modified organisms (GMOs). It supports traceability and accountability at every stage—from farms to processing facilities and trading entities—helping companies meet growing consumer and regulatory demands for sustainability. Three Levels of Certification Offered Depending on your role in the supply chain, Shark Certification Pvt. Ltd. can assist with the appropriate level of certification: Level I – Agricultural Production: For farms and growers, this includes the entire production area, encompassing both cultivated and non-cultivated zones. Level II – Storage, Transport & Trading: Focused on ensuring traceability and GMO-free integrity during handling and distribution of goods. Level III – Industrial Processing: Tailored for facilities involved in processing, manufacturing, or transforming raw agricultural products. Industries and Products Covered ProTerra Certification applies across a wide range of sectors such as agriculture, floriculture, horticulture, food processing, retail, and transport. Eligible products include but are not limited to: Soy, maize, rice, sugarcane, sunflower, rapeseed Fruits, vegetables, nuts, spices, and tea Bananas, coconut, palm oil, flowers, and plants Why Choose Shark Certification Pvt. Ltd.? Located in Indore, Shark Certification Pvt. Ltd. is your trusted partner for achieving ProTerra Certification. We combine industry expertise, global standards, and local knowledge to deliver reliable, timely, and cost-effective certification services. Our auditors are trained to work across multiple sustainability frameworks, allowing clients to bundle ProTerra Certification with complementary programs such as: Bonsucro ISCC Plus & ISCC EU RSPO Food Safety & Non-GMO Labeling Programs Key Benefits of ProTerra Certification Market Advantage: Meet rising global demand for sustainably sourced, GMO-free products. Brand Credibility: Enhance trust and reputation with independent third-party verification. Supply Chain Transparency: Ensure full traceability from farm to final product. Environmental Responsibility: Contribute to biodiversity conservation and climate action. Corporate Social Responsibility: Show commitment to fair labor practices and community welfare. Join the Global Movement for Sustainable Agriculture At Shark Certification Pvt. Ltd., we’re committed to helping producers, processors, and traders align with global best practices through ProTerra Certification. With rising awareness around the environmental and social impact of food systems, now is the time to showcase your dedication to a better future.

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.

FSSAI Compliance Services in Indore By Shark Certification Pvt. Ltd. – Your Trusted Food Safety Partner Under Section 31(1) & 31(2) of the Food Safety and Standards Act, 2006, every Food Business Operator (FBO) in India is legally required to obtain FSSAI Registration or License—whether you're a street vendor or a multi-national food brand. At Shark Certification Pvt. Ltd., we offer complete FSSAI compliance services to help food businesses across Indore and India meet mandatory regulatory requirements with ease and confidence. Who Needs FSSAI Registration or License? The FSSAI License/Registration is mandatory for businesses including (but not limited to): Small vendors, hawkers, and temporary or permanent food stalls Dairy businesses and milk chilling units Edible oil and vegetable oil processing units Slaughterhouses and meat processing facilities Food manufacturers, processors, and packaging units Proprietary and novel food producers (with FSSAI product approval/NOC) Cold storage, warehouse operators, and transporters (including refrigerated vans, milk tankers) Wholesalers, distributors, marketers, and retailers Hotels (star/non-star), restaurants, bars, and food chains Canteens, caterers, messes, clubs, and food vending agencies Home kitchens, dabbawalas, banquet halls, and religious food arrangements Importers, exporters, and e-commerce food businesses Government departments, corporate food outlets, airports, seaports, railways, and bus depots Mid-day meal kitchens and public food distribution centers Our FSSAI Compliance Services Include: At Shark Certification, we offer end-to-end FSSAI compliance support for businesses of all sizes and industries: New FSSAI Registration / State License / Central License Renewal of existing Registration or License Modification of license details including product category, address, or business structure Annual Return Filing (Form D1 / D2) and related declarations Assistance in Revocation of Suspended Licenses FSSAI Certified Training for FBOs and staff by qualified food safety trainers Facility Hygiene Audits by certified auditors Pre-inspection Surveys to prepare for official FSSAI audits and fix gaps before inspection Consultation on Labeling, Packaging, and Legal Metrology Norms Timely Alerts and Reminders for license renewal and return filing Why Choose Shark Certification Pvt. Ltd.? Certified Experts with deep industry and regulatory experience Accurate and Error-Free Filing with proper due diligence Confidentiality and Data Security assured Local Presence in Indore for better accessibility and faster service Free Initial Consultation to assess your FSSAI readiness Customized Compliance Plans for startups, SMEs, and large enterprises Training and Support throughout the certification journey Renewal and Filing Alerts via WhatsApp, Email, and SMS Updated Insights and Newsletters for food businesses Contact Us Today Ready to get your FSSAI Registration or License in Indore or any part of India? Let the experts at Shark Certification Pvt. Ltd. guide you through every step—from documentation to audit support.

‘Agmark’ is a Quality Certification Mark of the Government of India given to products confirming to scientifically laid down quality standards. Products commonly certified under AGMARK Honey Ghee, Butter Chillies, Turmeric, Curry powder, Garam Masalas, Cardamom, Cumin, Coriander and other curry powders. Vegetable Oils Spices Wheat, Atta, Maida, Suji, Besan, Pulses and many more items required by customers. Certificate of Authorization It is given to the packers authorizing them to grade their Commodity under AGMARK. Period of Validity will be 5 years. For granting new certificate of authorization separate application for each commodity should be produced. Documents to be given along with application Sketch of the premises:- Declaration regarding Proprietorship/Partnership etc Ownership of the premises Ownership of trade brand label Use of good grade quality containers for packing commodities. All declarations has to given in five rupees stamp label attested by notary public. A copy of licence from Panchayat/Municipality. Bank reference:- Letter from the bank regarding the transaction to the packer with the bank List of machineries. Specimen signature of authorised persons attested by the proprietor / managing partner. Medical fitness certificate of employee. Specimen copy and sketch of trade brand label

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.