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A leader in Bangladesh’s pharma sector

Article - July 9, 2012
Leading Bangladeshi company Incepta Pharamaceuticals Ltd. was established in 1999 with a vision to become a research based global pharmaceutical company in addition to being a highly efficient generic manufacturer. Today it exports its high quality products to 40 countries around the world
Incepta Pharmaceuticals Ltd. is a leading pharmaceutical company in Bangladesh established in the year 1999. The company was established with a vision to become a research based global pharmaceutical company in addition to being a highly efficient generic manufacturer. Company aims to discover and develop innovative, value-added products that improve the quality of life of people around the world and contribute towards the growth of Bangladesh.

Incepta is committed to the development, manufacturing, control and distribution of safe & effective pharmaceuticals products in compliance with current regulatory requirements. Incepta has state-of-the-art facility, robust technology, validated processes and high quality standard. To ensure these, Incepta continues to develop quality management system with personnel of appropriate background, knowledge, training and experience.

Incepta currently has a very big manufacturing facility located at Savar, 35 kilometer away from the center of the capital city Dhaka. The company currently produces various types of dosage forms which include tablets, capsules, oral liquids, ampoules, dry powder vials, powder for suspension, nasal sprays, eye drops, creams, ointments, lotions, gels, prefilled syringes, liquid filled hard gelatin capsules, lyophilized injections etc. in this facility. Apart from general products this site also has a very large human vaccine R&D and production facility. Very recently another facility for biologically derived products has started its operation.

At its second site in Dhamrai, Dhaka the newly setup potent drug facility has just started producing oral and injectable hormonal contraceptives. This facility has very large production capacity of 130 million ampoule and vials and 20 billion tablets per year. Several more finished formulation units are being set up at this new location. Over the last decade Incepta has continuously invested in expanding and modernization of its manufacturing facility and has developed an advanced technology based facility that is capable of matching the standards of the developed world.

Since launching the first product in early 2000, Incepta has been launching new and innovative products in order to fulfill unmet demand of the medical community in Bangladesh. The focus has been to bring newer and more technologically advanced molecules to Bangladesh. So far the company has pioneered the introduction of 124 generics in Bangladesh. Up to May 2012 it has launched more than 334 generics with a total of 639 presentations. The company produces a wide variety of dosage forms covering nearly all the major therapeutic classes.

High focus on quality and timely introduction of much needed essential medications previously unavailable in the country has enabled Incepta to become the second largest pharmaceutical company of the country by 2008, just eight years into operation.

The company specializes in value added high technology dosage forms like sustained release tablets, quick mouth dissolving tablets, effervescent tablets, barrier coated delayed release tablets, prefilled syringe products, Insulin and Insulin analogue and biological products, among others . It has established a modern research and development laboratory for the development of new, advanced dosage forms for various drugs and devices like poorly soluble drugs, dry powder inhalers, coated pellets, modified release products, taste masked preparation etc.

Incepta has a very competent sales team, which promotes the specialties throughout the country. The company virtually covers every single corner of the rural as well as urban area of Bangladesh. It has its own large distribution network having 18 depots all over the country.

Company's state-of-the-Art R&D lab employs sophisticated and advanced technology to bring newer products through research hitherto unknown in this country. Such activities have not only benefited the company but also the total pharmaceutical sector of the country. The company also intends to embark into the production of Active Pharmaceutical Ingredient (API). Plans are underway to get into reverse engineering and analogue research in order to produce new API.

Incepta Vaccines Limited, a sister concern of Incepta Pharmaceuticals, has already established a State-of-the-Art Human Vaccine production and research and development facility for both viral and bacterial vaccine. Incepta has the largest animal house of the country for testing potency and toxicity of the vaccines produced. Incepta Vaccines has so far launched three human vaccines in the Bangladesh market. Through this Incepta has emerged as the first Bangladeshi company to acquire the technology to produce human vaccine. Incepta can produce any dose size from 0.1 ml to 15 ml, with four different products being produced simultaneously. It has the capacity to fill 108 million vials and 72 million ampoules per year giving a combined capacity of 180 million vials and ampoules. At present the local demand in Bangladesh is around 30 million only. This very large production capacity will allow the company to supply its vaccines both nationally as well as globally.

Formulation Research & Development

Research has always been a critical thrust area for Incepta as it is the foundation upon which our strategy to introduce new products and delivering quality products to customers' stand. As a result of these efforts in R & D Incepta has been successful in developing and introducing quality products faster than its competitors.

Investment in acquiring and developing advanced technology and incorporating it into manufactured product is always of topmost priority. Incepta has built up a research and development facility equipped with sophisticated state-of-the-art equipment. The research and development team is highly experienced multidisciplinary. The objective of this R & D strength is to develop new drug delivery system and various dosage forms like controlled release, immediate release, melt in the mouth, effervescent formulations, nasal preparations, cream & ointment preparations, liquid injections like Insulin and large volume amino acid solution for injection, powder filled vials, prefilled syringe injections, Depot injections, ophthalmic products, lyophilized products in key therapeutic segments in addition to the conventional dosage forms.

Recent addition in the line of R & D is introduction of human vaccine, biologically derived products and potent drugs like hormonal contraceptive development capabilities. Incepta is continuously venturing into more and more critical and high technology oriented product lines that require high end technological knowhow.

The formulation and development at Incepta R & D ensures pre-formulation studies to check bio-chemical action of ingredients followed by trials to assess efficiency and reproducibility of formulation (process validation). It also undertakes stability study following ICH guide-line to check physical, chemical, and microbiological aspects of formulation. Then the process is standardized for uniform quality. Then the technology is transferred for commercial production. The R & D also develops and performs analytical method validation for each product it develops.

Incepta has a separate Galenical laboratory for R & D, equipped with all the necessary machineries & equipments of GMP standard in small scale for the team to develop products.

Analytical development is supported by the Quality Control Department. Quality Control Department is equipped with highly sophisticated instruments like UPLC, Gas Chromatography, Atomic absorption spectrophotometer, FTIR etc. A dedicated team is involved in the development and validation of methods of API, raw materials & finished products. Highly sophisticated microbiology laboratory has been setup to cater to the need for quality control of regular products as well as control of all the different biological products that the company produces. The R & D team has pioneered the technology development and subsequent introduction of 124 new products for the first time in Bangladesh market.

International recognition and compliance with internationally accepted norms of Good Manufacturing Practice (GMP)

The quality management system of Incepta Pharmaceuticals Limited is established in a frame to describe its operations in different documents and practices which is based on the principles of PICS and WHO guidelines. The company maintains a Quality Manual that describes the Quality Policy of Incepta Pharmaceuticals Limited. The responsibilities for the technical aspects of Quality Assurance are defined in the Quality Manual. It encompasses all activities necessary to generate, maintain and verify the quality of drugs.

Compliance with GMP standards is a must for any pharmaceutical company and Incepta adheres to the guidelines rigorously. In Bangladesh the regulatory authority for the pharmaceutical companies is “The Directorate General of Drug Administration, Ministry of Health & Family Welfare, Government of the Peoples Republic of Bangladesh”. Incepta ensures compliance with the local regulatory requirements.

Over the years Incepta Pharmaceuticals Ltd has also been accredited with the European Union GMP certification for its Solid Dosage form's plant at Zirabo, Savar, in Bangladesh, a rare and one of the most coveted certification for regulated markets. The Solid Dosage form's Plant of the company was inspected by the European authorities and found to be complying with the Manufacturing and Quality Control Standards as per the European Good Manufacturing Practices.

UK MHRA, the regulatory authority of England has inspected the Zirabo plant of Incepta Pharmaceuticals Ltd in February 2011. Incepta received the GMP approval for its solid dosage form facility in July 20011 for its own formulated products allowing marketing in UK and other European countries.

Directorate General of Drugs and Pharmaceuticals, Ministry of Health of the Republic of Turkey issued GMP certificates to Incepta Pharmaceuticals Ltd for Tablets, Capsules and Lyophilized Products. Unlike single product GMP certificate which is the normal trend, Incepta received GMP certificate for multiple full lines. Incepta has also received GMP certification from a number of other countries. The relevant departments of the Health Ministry of these countries have issued these GMP certificates.

In 2004 Incepta was inspected by UNICEF and UNDP and accepted as a potential supplier. In 2005 Incepta started supplying products to UNICEF locally in Bangladesh. Subsequently in 2009, Incepta was accepted by the global headquarters of UN agencies UNICEF, UNESCO, UNDP and UNRWA at Copenhagen, Denmark and became enlisted as their potential global supplier. In 2012 Incepta was also registered with the UN agency UNDP.

Incepta’s Export to the world

The company’s vision is to become a leading research based dosage form manufacturing company with global presence within a short period of time. Within five years of starting export operations, Incepta now sells its products in 40 countries. This has become possible due to an intellectual pool of some of the best minds. Starting in late 2006, Incepta already has registration of more than 350 products and many more in registration pipeline in different countries around the globe. Further negotiation with possible business partners and product registration is going on in many more countries.

Incepta currently sells its product in many countries of Asia, Africa, Central and Latin America and has started to sell in Europe. In Europe the company has registered its own product in UK and has started selling. Incepta is taking special efforts to ensure presence in the rest of the globe.

Partnerships and technology transfer in export operation

Initially exploring through distributorship and agency agreement, Incepta has now setup other types of partnerships in a number of different countries. It is selling its arthritis medication registered with the UKMHRA authority in partnership with Blackrock Pharmaceuticals, UK.

In the US market it has partnered with Abon Pharmaceuticals LLC and has filed a product for registration with the USFDA authority. Another partnership for technology transfer is now underway in Algeria. Nadpharmadic a new pharmaceutical company of Algeria is in the process of introducing products in the Algerian market with Incepta being the technology provider. Nadpharmadic is expected to launch the first of such products in July 2012.

Currently the company is exploring distributorship, contract manufacturing, in licensing, technology partnership and many other forms of cooperation in various countries around the world. Companies around the world can benefit from partnership with Incepta as Incepta offers a very large portfolio of generic products to choose from. Focus on ensuring high quality and cost effectiveness makes this portfolio even more attractive to potential customers. The company is striving to fulfill its long term vision to provide people globally with high quality health care products at affordable prices in order to improve access to medicine.

Information technology

On 15th January 2011, Incepta implemented globally acclaimed ERP software system - SAP. Incepta is the first Bangladeshi pharmaceutical company to implement SAP to manage resources throughout the company operation. This world class resource management system allows the company to become more efficient and effective in its day to day operation.

Human Resource 

Just as strong roots provide the foundation for a growing tree, a company’s growth is supported by the strength of its employees. Incepta is an equal opportunity employer and provides employment for people from different backgrounds. At Incepta people build success for the company. For us, success means that each and every employee contributes to expanding our pool of experience, each and every day. To achieve corporate purpose and mission, Incepta affirms our values of integrity, respect for people, innovation, performance and leadership.

More than 4500 individuals from diverse disciplines including pharmacy, microbiology, MBA, accounting, engineering, biochemistry, chemistry, microbiology, medicine are working nationwide under the umbrella of Incepta. Around 53% of people are graduates or higher educated. All the skilled and professional personnel are set at their very appropriate responsible positions.

Incepta maintains a dynamic and professional working environment. Employees get enough exposure to challenging assignments and opportunities that sharpen their talents to embrace new capabilities. Talent and performance are the pillars of career progression at Incepta.

Corporate Social Responsibility/CSR

Incepta strongly believes that commitment towards people and the society as a whole positively contributes towards its business objective. Incepta achieved its tremendous commercial success through its honesty and sincerity in business policies. The company aims to become the Nation's most admired company through its honest and intelligent approach. Company management strives to support community where they live and also the nation as far as possible in times of need.

Incepta believes it can thrive only if the nation remains healthy. Incepta gives emphasis to its practice of Corporate Social Responsibility (CSR) and evidence of this commitment is found in its dealing with clients, suppliers, employees, Government and the society at large.

Company pays tax and VAT to the Government and also settles bank and suppliers liabilities in a timely fashion and disburses benefits to employees on time. Incepta considers its employees to be valuable assets and protects their rights and provides a full range of staff facilities including life insurance, disbursement of 5% of the company profit, home loan, transport facility, benevolent fund, subsidized food, medical facility etc. apart from provident fund and gratuity. Incepta maximizes safety in workplace for its employees and child labor is strictly prohibited. Incepta strives to provide its employees an enabling environment that facilitates realization of their full potential.

As its commitment to society the company donates medicine to the Government Relief Fund during natural disaster. Incepta also provides financial assistance for expensive treatment including heart and cancer and disburses its donation fund for the relief of distressed people every year. More importantly Incepta continues to introduce life-saving "import-substitute medicines" at affordable price for the people of Bangladesh.

Bangladesh Pharmaceutical Industry

Bangladesh domestic pharmaceutical market is now valued at US$1.136 billion. There has been a marked value wise growth of the market at the rate of 23.59% over that of 2010, according to data released by IMS Health Bangladesh. These data are based on the country’s retail sales only. Institutional sales and import of drug has remained outside the purview of the study. According to Business Monitor International (BMI) report June 2009 issue the market is expected to grow to US$1.72 billion by 2014.

The development of Pharma industry in Bangladesh dates back to early 50’s when several national companies started operation. Industry further progressed due to establishment of several multinational companies in 60’s. One of the major reasons of development is the availability of qualified pharmacists in Bangladesh. Currently about 18 public and private Universities offer Pharmacy education. The strength of the local industry lies in the steady supply of Pharmacist, Doctors, Microbiologists, Engineers, Biochemists and Chemists from 40 plus public and private Universities. So, no shortage of educated, highly trained Human Resources. Industry developed significantly during 80’s because of country’s emphasis to self-sufficiency in medicine. Local Industry started upgrading to international standard in 90’s because of huge export potential. More than 100 companies are operational in the country and some of the leading companies have already reached International Standard.

Local industry fulfils about 96% of national requirement of 150 million people. Only some vaccines and anti-cancer drugs are imported. In recent times, the country faced many natural calamities followed by epidemics of various diseases. Local industry was able to provide full support. Bangladesh has significant surplus capacity in pharmaceuticals production. After catering to the demand of its people, products are being exported to 78 countries including some advanced countries. Current exports are going to Asia, Africa, Central & Latin America and Europe. Bangladeshi products are of international standard while the average cost is less than one-third compared to western products. Quality of products can be tested by scientific method leading to eradication of all confusion on quality standard. Among all the major competitors in the world Pharma sector, except India, Bangladesh has highest number of English speaking human resources. So, Bangladesh is will get preference for Technology Transfer for under license manufacturing in other countries, Contract Manufacturing or setting up Contract Research Organizations.

There are already five companies approved by regulatory authorities of developed world. Another five to six companies are on the verge of getting approval. Within a few more years many other Bangladeshi companies will be fully inspected & ready for export to developed countries. Bangladesh is now ready to offer products of International Standard and at much lower cost resulting into huge savings for the buyers.

India & China will be busy to feed their large population. Bangladesh can be like Switzerland, a small country but with big pharmaceutical companies. Bangladesh with its English speaking, skilled workforce with surplus state-of-the-art facility & economy of scale can fulfill the global demand of medicine. In very short course of time Bangladesh can become a global supplier of high quality, low cost generic medicine.