GMP Certification Guide for Pharmaceutical and Food Manufacturers in India

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Introduction: Why GMP Is the Foundation of Manufacturing Compliance in India

In the world of manufacturing — whether you produce life-saving medicines or everyday packaged food — there is one standard that sits above all others in terms of regulatory weight, market access, and consumer trust: Good Manufacturing Practices, universally known as GMP.

GMP is not a quality management system you adopt voluntarily to win a tender or impress a buyer. In India, GMP compliance is a legal prerequisite for manufacturing pharmaceuticals, medical devices, cosmetics, and food products intended for sale — domestic or international. It is enforced by multiple regulators, embedded in multiple statutes, and the consequences of non-compliance range from product recalls and license suspension to criminal prosecution.

Yet for thousands of small and medium manufacturers across India, GMP remains poorly understood. Many confuse it with ISO certification. Many assume it applies only to large multinationals. Many treat it as a one-time audit exercise rather than a continuous operational philosophy.

This guide changes that. It covers what GMP actually means in the Indian regulatory context, which laws mandate it, how it applies differently to pharmaceutical and food manufacturers, what the certification and audit process looks like, and what you must do to build and sustain a compliant manufacturing operation in 2025.

Section 1: What Is GMP? The Foundational Concept

Good Manufacturing Practices are a system of documented guidelines, standard operating procedures, and operational controls that ensure products are consistently produced and controlled to the quality standards appropriate for their intended use. The core philosophy of GMP can be summarized in one sentence: document what you do, do what you document, and prove it.

GMP addresses every dimension of the manufacturing process that can affect product quality and safety: the design and maintenance of manufacturing facilities, the qualification and calibration of equipment, the sourcing and testing of raw materials, the training and hygiene of personnel, the control of the production process itself, in-process testing and quality checks, the testing of finished products before release, the packaging and labeling process, storage and distribution conditions, and the handling of complaints and product recalls.

The GMP concept originated in the United States in the 1960s following drug disasters caused by manufacturing failures. It was subsequently adopted by the World Health Organization (WHO), which published its own GMP guidelines that became the global benchmark — particularly for developing nations including India.

Today, GMP frameworks exist at multiple levels: WHO-GMP (the international standard), Schedule M GMP (India’s pharmaceutical standard under the Drugs and Cosmetics Act), EU-GMP (the European standard required for exports to Europe), US FDA cGMP (required for export to the United States), and FSSAI’s Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, which encode GMP principles for food manufacturers.

Understanding which GMP standard applies to your manufacturing operation — and at what level — is the first critical step in building a compliant facility.

Section 2: The Legal Framework — Which Laws Mandate GMP in India?

GMP in India is not governed by a single omnibus statute. Different sectors have different regulatory homes, and the GMP requirements embedded in each are enforced by different authorities.

For Pharmaceutical Manufacturers:

The primary statute is the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Schedule M of the Rules lays down the GMP requirements for premises, plant, and equipment for the manufacture of drugs. Every pharmaceutical manufacturer holding a manufacturing license under the D&C Act is legally required to comply with Schedule M GMP. The regulatory authority is the Central Drugs Standard Control Organisation (CDSCO) at the central level, and the State Drug Controllers at the state level for state-licensed manufacturing.

In 2023, the Ministry of Health and Family Welfare notified a significantly revised Schedule M — aligning India’s pharmaceutical GMP standards much more closely with WHO-GMP and EU-GMP. This revised Schedule M came into effect with phased implementation timelines: large manufacturers were required to comply by December 2024, while medium and small manufacturers have timelines extending through 2025–2026. This revision is the most consequential update to Indian pharmaceutical GMP in decades.

For Food Manufacturers:

The governing statute is the Food Safety and Standards Act, 2006 and the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. Schedule 4 of these regulations lays down the GMP and Good Hygienic Practices (GHP) requirements for food business operators. The regulatory authority is FSSAI — the Food Safety and Standards Authority of India. All food manufacturers holding an FSSAI license are required to comply with Schedule 4 GMP standards.

For food manufacturers targeting export markets, additional GMP-aligned certifications — including HACCP, ISO 22000, FSSC 22000, BRC, and SQF — are typically required by international buyers and importing country regulations.

For Cosmetics Manufacturers:

Cosmetics in India are regulated under the Drugs and Cosmetics Act, 1940 (cosmetics fall under the definition of “drug” for regulatory purposes). Schedule M-II of the Rules lays down GMP for cosmetics manufacturers. From April 2020, cosmetic manufacturers are required to hold a manufacturing license and comply with these GMP norms — a significant regulatory tightening compared to the earlier regime.

For Medical Device Manufacturers:

The Medical Devices Rules, 2017 (amended 2020) and the associated Quality Management System requirements — based on ISO 13485 — govern GMP for medical device manufacturers. CDSCO is the regulatory authority.

Section 3: GMP for Pharmaceutical Manufacturers — A Deep Dive

For pharmaceutical manufacturers, GMP compliance is the most demanding and consequential regulatory obligation they face. The revised Schedule M, notified in 2023, represents a wholesale upgrade of India’s pharmaceutical GMP framework. Here is what it requires across all key dimensions:

Premises and Facilities:

Manufacturing premises must be designed, constructed, and maintained to facilitate cleaning, avoid cross-contamination, and prevent mix-ups. Specific requirements cover floor-to-ceiling finishes (smooth, impervious, non-shedding surfaces), HVAC systems with defined air change rates and pressure differentials for different manufacturing zones, dedicated areas for raw material storage, in-process storage, finished goods storage, and rejected material quarantine, defined access control between clean and less-clean areas, and dedicated pest control programs with documented monitoring.

For sterile product manufacturers — injectables, ophthalmic preparations, and certain biologics — the requirements are dramatically more stringent, with classified cleanrooms (Grade A through D), continuous environmental monitoring, and validated air filtration systems.

Equipment:

All manufacturing equipment must be qualified before use. Equipment qualification follows a defined sequence: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Critical equipment — mixers, granulators, tableting machines, filling lines, autoclaves — must be periodically requalified and maintained on documented preventive maintenance schedules. All measuring and monitoring instruments used in production and quality control must be calibrated against traceable standards, with calibration certificates maintained and expiry dates tracked.

Raw Material Control:

Every raw material — active pharmaceutical ingredient (API), excipient, primary and secondary packaging material — must be sourced from approved vendors. Vendor approval requires an audit of the supplier’s manufacturing facility and a review of their quality documentation. Each incoming lot of raw material must be sampled and tested against specifications before it is released for use in production. Raw materials must be stored under defined conditions — temperature, humidity, light protection — with traceability from receipt through use in each batch.

Production and Process Control:

Each product must have a validated manufacturing process. Process validation demonstrates that a manufacturing process consistently produces a product meeting its predetermined specifications. For oral solid dosage forms, this typically requires three consecutive commercial-scale batches manufactured under routine conditions, all meeting specifications, with detailed documentation of process parameters and in-process controls.

Batch Manufacturing Records (BMRs) — sometimes called batch records or batch tickets — must document every step of the manufacturing process for every batch: who performed each step, what equipment was used, what quantities were used, what in-process results were obtained, and any deviations from the standard process.

Quality Control Laboratory:

A separate Quality Control department — independent of the production department — must conduct testing of raw materials, in-process samples, and finished products. The QC laboratory must be equipped, staffed, and managed to perform all required tests to validated methods. All laboratory instruments — HPLC systems, dissolution apparatus, Karl Fischer titrators, UV-Vis spectrophotometers — must be qualified and calibrated. Laboratory notebooks and analytical records must be contemporaneously completed and subject to second-person review.

Change Control, Deviation Management, and CAPA:

GMP is as much a documentation discipline as a physical one. Every change to a validated process, approved specification, or GMP-critical procedure must go through a formal Change Control process — impact assessment, approvals, implementation, and verification. Every deviation from a documented procedure must be formally recorded, investigated for root cause, and closed with a Corrective and Preventive Action (CAPA). These systems are the heartbeat of a functioning pharmaceutical quality management system.

Product Release:

No batch of finished pharmaceutical product may be dispatched to the market until it has been released by a qualified Approved Person (in WHO-GMP parlance) or the Head of Quality — who must review the complete Batch Manufacturing Record, all QC test results, all deviations and their resolutions, and confirm the batch meets all specifications before issue of the Certificate of Analysis and formal batch release.

Section 4: GMP for Food Manufacturers — Schedule 4 and Beyond

For food manufacturers, GMP compliance under FSSAI’s Schedule 4 is the baseline legal requirement embedded in every State and Central License. It translates the GMP philosophy into the food manufacturing context — with strong emphasis on hygiene, contamination prevention, and process controls.

Premises and Layout:

Food manufacturing premises must be located away from environmentally polluted areas and flood-prone zones. The layout must ensure a hygienic flow of operations — raw material reception, processing, packaging, and dispatch — that minimizes the risk of cross-contamination between raw and processed food. Floors, walls, ceilings, and doors must be smooth, impervious, and easily cleanable. Adequate lighting and ventilation must be provided. Pest control must be documented and routinely conducted.

Equipment and Utensils:

All equipment and utensils that come into contact with food must be made of food-grade, non-toxic materials — stainless steel (food grade) is the universal standard for contact surfaces. Equipment must be designed for easy cleaning and must be cleaned and sanitized at defined frequencies following documented cleaning procedures. Wooden utensils and surfaces are prohibited in food contact applications.

Personal Hygiene:

Food handlers must maintain a high standard of personal hygiene — clean protective clothing, head coverings, and footwear. Handwashing facilities must be provided at strategic points, and handwashing protocols must be enforced and documented. Food handlers with infectious diseases, skin conditions, or open wounds must be excluded from food contact areas. No eating, smoking, or spitting is permitted in food processing areas.

Raw Material Sourcing and Incoming Quality Control:

Raw materials must be procured from approved sources and inspected on arrival. Incoming lots not meeting specifications must be rejected and segregated. Raw materials must be stored under appropriate conditions — temperature, humidity, pest-proof storage — and used on a FIFO (First In, First Out) basis.

Process Controls and Critical Control Points:

Food manufacturers, particularly those targeting larger markets or export, are expected to implement HACCP — Hazard Analysis and Critical Control Points. HACCP is a systematic approach to identifying biological, chemical, and physical hazards in the manufacturing process, determining the points at which those hazards can be controlled (Critical Control Points), setting limits, and monitoring those limits continuously. For export-oriented food manufacturers, HACCP implementation is typically mandatory — and must be certified by an accredited certification body.

Labeling and Traceability:

All finished food products must be labeled in compliance with FSSAI’s Labeling Regulations — including the FSSAI license number, manufacturing date, best-before date, list of ingredients, and nutritional information. Every batch must be traceable from finished product back through production records to incoming raw material lots — this traceability is the foundation of any effective product recall.

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Section 5: WHO-GMP Certification — What It Is and Why It Matters

WHO-GMP certification is the gold standard for pharmaceutical manufacturers in India who supply to export markets — particularly to government procurement agencies in Africa, Southeast Asia, Latin America, and WHO-listed UN procurement programs.

What WHO-GMP Certification Involves:

WHO-GMP certification is issued by the CDSCO (or state drug authorities for state-licensed manufacturers) following an inspection of the manufacturing facility against the WHO Technical Report Series (TRS) GMP guidelines — primarily WHO TRS 986 Annex 2 and related guidelines. The inspection covers all aspects of the facility: premises, equipment, documentation, production, quality control, and quality management systems.

Upon satisfactory inspection, CDSCO issues a WHO-GMP Certificate (sometimes called a GMP Certificate for Export) which is accepted by most importing country regulatory authorities as evidence that the facility meets internationally recognized GMP standards.

Why Indian Pharma Manufacturers Need WHO-GMP:

India is the world’s largest supplier of generic medicines to developing countries. A significant proportion of this supply goes through procurement programs run by UNICEF, the Global Fund, PEPFAR, and national government procurement agencies — all of which require WHO-GMP certification as a prerequisite for supplier qualification. Without WHO-GMP certification, an Indian pharmaceutical manufacturer effectively has no access to these markets.

The Inspection Process:

A WHO-GMP inspection is typically conducted by a team of two or more drug inspectors over 3 to 5 days for a standard solid-dosage form facility, and longer for sterile product facilities. The inspectors follow a structured protocol, examining physical facilities, reviewing documentation (SOPs, BMRs, validation records, QC data), interviewing personnel, and conducting a closing meeting at which observations are shared. Observations are classified as critical (major risks to product quality or patient safety), major (significant GMP failures), and minor (isolated departures from best practice). A certificate is issued only when all critical and major observations are satisfactorily resolved.

Section 6: EU-GMP and US FDA cGMP — For Export-Oriented Manufacturers

For pharmaceutical manufacturers targeting exports to the European Union or the United States — the two highest-value pharmaceutical markets — the regulatory bar is significantly higher than WHO-GMP.

EU-GMP:

The EU-GMP framework is set out in EudraLex Volume 4 — the EU Guidelines for Good Manufacturing Practice for Medicinal Products. Indian manufacturers exporting to the EU must be inspected and approved by the competent authority of a European Union member state — the MHRA (UK, for historical approvals), ANSM (France), BfArM (Germany), or others. An EU-GMP Certificate is issued following a satisfactory inspection and is listed on the EudraGMDP database, which is publicly accessible. EU inspections are exhaustive — typically 5 to 7 days for complex facilities — and cover not just the physical facility but the entire pharmaceutical quality system, including data integrity, computerized systems validation, and supplier quality management.

US FDA cGMP:

Current Good Manufacturing Practices (cGMP) under the US FDA are codified in 21 CFR Parts 210 and 211 for finished dosage forms, and 21 CFR Part 211 for APIs. US FDA inspections of Indian facilities are conducted by FDA investigators operating out of the FDA India office, and they have become significantly more stringent since the wave of high-profile 483 observations and Warning Letters issued to major Indian pharma companies between 2013 and 2020. Data integrity — the completeness, consistency, and accuracy of GMP records — has been the central focus of US FDA inspections in India. A single significant data integrity finding can result in a Warning Letter, import alert, and the effective exclusion of all products from that facility from the US market.

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Section 7: Food Safety Certifications Beyond FSSAI — HACCP, ISO 22000, FSSC 22000, BRC

For food manufacturers with ambitions beyond the domestic market — or those supplying to organized retail, institutional buyers, or export markets — FSSAI compliance is necessary but not sufficient. International buyers, retail chains, and importing country authorities typically require one or more of the following third-party food safety certifications:

HACCP Certification:

HACCP — Hazard Analysis and Critical Control Points — is a globally recognized food safety management methodology rather than a comprehensive management system standard. HACCP certification, issued by accredited certification bodies, demonstrates that a food manufacturer has identified all food safety hazards in its process, established critical control points, set critical limits, and implemented monitoring, corrective action, and verification procedures. It is a prerequisite for many export markets and a common requirement of large domestic institutional buyers.

ISO 22000:2018:

ISO 22000 is the international standard for Food Safety Management Systems (FSMS). It combines HACCP principles with a comprehensive management system framework — similar in structure to ISO 9001. Certification is issued by accredited third-party certification bodies (such as Bureau Veritas, SGS, TÜV SÜD, DNVGL) following a two-stage audit process. ISO 22000 certification is recognized globally and is a strong credential for food manufacturers supplying international markets.

FSSC 22000:

The Food Safety System Certification 22000 (FSSC 22000) is a comprehensive food safety certification scheme that builds on ISO 22000 and adds sector-specific pre-requisite programs (PRPs). It is recognized by the Global Food Safety Initiative (GFSI) — the benchmark recognition that signals a food safety scheme is robust enough to be accepted by major global retailers and food companies including Walmart, Tesco, Nestlé, and Unilever. For food manufacturers supplying to global retail chains or multinational food companies, GFSI-recognized certification is typically mandatory.

BRC Global Standards (BRCGS):

The British Retail Consortium Global Standard for Food Safety is one of the most widely recognized GFSI-benchmarked standards, particularly for food manufacturers supplying to UK and European retail markets. BRCGS certification is graded (AA, A, B, C, D) and the grade appears on the certificate — making it a transparent, market-differentiating credential.

SQF (Safe Quality Food):

SQF is a GFSI-recognized food safety and quality certification scheme particularly prevalent in the United States market. Food manufacturers targeting the US retail and food service sector frequently need SQF certification as a supplier prerequisite.

Section 8: Building a GMP-Compliant Operation — Practical Steps

Whether you are a pharmaceutical startup setting up your first manufacturing facility or an established food manufacturer preparing for a certification audit, the pathway to GMP compliance follows a consistent structure.

Step 1 — Gap Analysis:

Before anything else, conduct a thorough gap analysis of your current operations against the applicable GMP standard — Schedule M (pharma), Schedule 4 (food), WHO-GMP, or whichever standard is your target. A gap analysis systematically compares what the standard requires with what you currently have in place, producing a prioritized list of corrective actions. This is most effectively done by an external consultant with regulatory inspection experience, who will see your facility as an inspector would.

Step 2 — Facility Upgrades:

Address infrastructure gaps identified in the gap analysis — HVAC upgrades, cleanroom construction or qualification, surface finish improvements, utility system documentation, pest control system formalization, and dedicated area segregation. Facility upgrades are often the most capital-intensive and time-consuming part of GMP remediation, so they must be addressed first to allow adequate time before the certification inspection.

Step 3 — Documentation Development:

Develop or upgrade your documentation system. The GMP documentation hierarchy runs from the Quality Manual (overarching GMP philosophy and policy) through Procedures (SOPs) to Records (completed forms, batch records, logbooks). Every GMP requirement must have a corresponding written procedure, and every execution of that procedure must generate a contemporaneous record. Documentation development is resource-intensive — a mid-sized pharmaceutical facility may have 300 to 500 SOPs.

Step 4 — Personnel Training:

Train all personnel on GMP principles, their specific role-based SOPs, and the documentation requirements. GMP training must be documented — training records must show who was trained, on what, when, and with what outcome. For pharmaceutical facilities, designated personnel in key roles — Head of Quality, Head of Production, Approved Person — must meet defined qualification and experience requirements.

Step 5 — Equipment Qualification and Process Validation:

Qualify all GMP-critical equipment and validate all critical manufacturing and cleaning processes. This is a substantial undertaking for a pharmaceutical facility — validation master plans, individual validation protocols, and validation summary reports must be prepared and executed. For food manufacturers, process validation of critical steps — pasteurization time-temperature, retort processes for canned food, fumigation procedures — is equally important.

Step 6 — Internal Audit:

Before the regulatory or certification inspection, conduct a thorough internal GMP audit — ideally using personnel who were not involved in writing the procedures being audited, or an external audit team. An internal audit under inspection conditions will surface residual gaps and give your team the experience of responding to audit observations.

Step 7 — Regulatory Inspection or Certification Audit:

For pharmaceutical manufacturers, apply to the CDSCO or State Drug Controller for inspection (or to the relevant international authority for EU-GMP or US FDA inspection). For food manufacturers seeking third-party certification, contract with an accredited certification body and schedule the certification audit. The initial certification audit for ISO 22000 or FSSC 22000 typically involves a Stage 1 (documentation review) and Stage 2 (on-site audit) within a defined timeframe.

Section 9: Common GMP Failures — What Inspectors Find Most Often

Understanding the most common GMP failures seen during regulatory inspections in India helps manufacturers prioritize their remediation efforts:

Data Integrity Failures: This is the number one finding in US FDA inspections of Indian pharmaceutical facilities — and increasingly in WHO-GMP inspections as well. Data integrity failures include deletion or overwriting of original raw data, backdating of records, unofficial “practice” runs on instruments before official runs, and analyst testing until a passing result is obtained. Data integrity failures are treated as the most serious category of GMP violation because they undermine the entire quality assurance system.

Inadequate Out-of-Specification (OOS) Investigations: When a QC test result falls outside specification, the investigation must be rigorous, documented, and scientifically justified. Common failures include conducting Phase I laboratory investigations inadequately, assigning OOS results to “analyst error” without documented evidence, and invalidating OOS results without proper justification.

Poor Cleaning Validation: Equipment cleaning procedures must be validated to demonstrate that they remove product residues, cleaning agents, and microbial contamination to acceptable levels. Many manufacturers have cleaning procedures but have never validated that those procedures actually work.

Inadequate Vendor Qualification: Approving raw material suppliers based on price and availability rather than a formal quality audit and ongoing monitoring is a persistent GMP failure — particularly for small manufacturers.

Incomplete or Retrospectively Completed Records: Records completed after the fact — even if accurate — violate the contemporaneity requirement of GMP. Inspectors look for evidence of retrospective completion: uniform pen strokes across a page, identical handwriting for records supposedly completed at different times, or implausible timestamps.

Section 10: Penalties for GMP Non-Compliance in India

For Pharmaceutical Manufacturers:

Under the Drugs and Cosmetics Act, 1940, manufacturing drugs in contravention of GMP standards (Schedule M) is a punishable offense. Penalties include cancellation or suspension of the manufacturing license by the State Drug Controller or CDSCO, product recall at the manufacturer’s cost, prosecution with imprisonment up to 3 years and fine, and in cases of adulteration causing death or grievous hurt, imprisonment up to life plus fine.

At the international level, a US FDA Warning Letter effectively bars all products from the cited facility from entering the US market until the facility is re-inspected and found compliant — a commercially devastating outcome that has cost several Indian pharmaceutical companies billions of dollars in lost revenue.

For Food Manufacturers:

FSSAI’s enforcement powers under the FSS Act, 2006 include suspension or cancellation of the food business license for GMP violations, product recall and destruction of non-compliant stock at the manufacturer’s cost, fines up to ₹5 lakh for food not meeting safety standards, and prosecution for adulteration causing injury or death, which can attract imprisonment up to life plus fine of ₹10 lakh.

Helpful Resources

For comprehensive regulatory compliance support — including GMP documentation, audit preparation, FSSAI licensing, CDSCO applications, and pharmaceutical regulatory consulting: LegalTax.in — Regulatory Compliance Services for Manufacturers

For trademark registration and intellectual property protection for pharmaceutical brands, food brands, and manufacturing company names and logos: LegalIP.in — IP and Trademark Registration for Indian Manufacturers

For affordable, fast trademark registration to protect your product names, brand labels, and manufacturing identity in Indian and international markets: OnlineTrademarkIndia.com — Trademark Registration for Food and Pharma Brands

Conclusion: GMP Is Not a Destination — It Is a Daily Practice

The most important insight this guide can leave you with is this: GMP compliance is not a one-time certification exercise. It is a living, daily operational discipline that requires consistent management attention, adequate resource allocation, trained and engaged personnel, and a genuine organizational commitment to quality.

The manufacturers who pass regulatory inspections with minimal observations are not those who prepared intensively in the three months before the audit. They are the ones who built GMP into their daily operations — where every batch record is completed correctly because that is simply how things are done, where every deviation is logged because everyone understands why it matters, and where quality is the responsibility of every person on the factory floor, not just the QA department.

In 2025, with India’s pharmaceutical and food sectors under unprecedented global scrutiny, and with domestic regulators better equipped and more active than at any point in history, the manufacturers who thrive will be those who understand that GMP is not a cost of compliance — it is the foundation of sustainable, trusted, market-leading manufacturing.

Get Expert Compliance Support Today

GMP certification is complex, documentation-intensive, and unforgiving of shortcuts. Whether you are preparing for your first Schedule M inspection, pursuing WHO-GMP certification for export markets, implementing HACCP for your food facility, or navigating a regulatory notice, professional support can mean the difference between a successful audit and a license suspension.

Connect with India’s trusted regulatory compliance experts. Visit LegalTax.in today for a consultation on your GMP readiness.

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Aman G

I’m Aman Arora aka Aman G — 10+ years in SEO and Digital Marketing, and I love getting results. I don’t just do SEO & Website Design; I build strategies that work. I’m a CA drop out, but what I enjoy most is helping entrepreneurs and NGOs reach their goals. For me, happy customers are the real reward.

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