Md. Halimuzzaman
DMD and CEO
Healthcare Pharmaceuticals Ltd
Since its inception, we have witnessed an amazing growth of Healthcare Pharmaceuticals Ltd, What is the secret behind it?
The history of HPL is the story of a passionate commitment to scientific excellence and investment in development and to provide innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases. HPL has established State-of-the-art manufacturing plant with World-class Advanced Technology not only for Generic molecules, but also for Biotech, Oncology, Hormone and many cutting edge segments. HPL has one of the largest and competent sales force and large distribution network of its own, operated from 27 different locations and catering 65000 pharmacies throughout the country. The demand of the pharmacies are being served in a day or two.
HPL’s growth story is based on rock solid quality, customer’s focus and testimony of our customers, compliance with the Regulatory agencies, partnering with the global giants for tech transfers and strong values and commitment of the employees. Responding to the evolving needs of society and making a meaningful impact on the quality of their lives is central to everything HPL does. HPL is committed to the WHO’s GMP and ICH (International Council for Harmonisation) guidelines as the core mantra to operate. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
Healthcare believes that pharmaceutical companies should not confine their quality at the manufacturing level, it has similar importance in the Post Marketing Surveillance (PMS) or Pharamcovigilence (PV) to monitor the safety and adverse reactions to the patients and to report to the regulatory agencies. HPL has strong Ethics and Compliance Committee to monitor the SOPs of the marketing engagement with the HCPs (Healthcare Professionals) for the sales and distribution of the products in alignment with the “Code of Pharmaceuticals Practices in Marketing” formulated by the Bangladesh DGDA (Directorate General of Drugs Administration) and USA guidelines for the pharmaceuticals companies to deal the HCPs.
While we are building our capacity for the manufacturing of the drugs for the difficult-to-treat disease, we are equally striving our access to the people of Bangladesh with the very affordable prices.
Many of your brands are innovative and market leaders. Is your market strategy or quality is the factor?
As a leader in the pharmaceutical industry, we realize our unique role of offering many innovative brands which are now leading the market. The main factor here is Quality. Quality is a cornerstone of all of our activities. We are associated with quality, innovation, customer satisfaction and tradition. We produce high quality products and services. The HPL quality management system is a combined responsibility of various functions starting from its manufacturing process to monitoring of distribution end points.
Quality and Customers orientation are a company commitment and the shared responsibility of all associates. This commitment will be maintained through having the competent people doing the right things, the first time, every time. We are assuring continued high quality through state-of-the-art technology, which develops and commercializes safe pharmaceutical products that enhance the quality of life. We are having a management team that is accountable for effective review and support of quality, through the prioritization, resourcing, and timely execution of quality-conscious decision-making. We are having an experienced workforce, equipped with continuing education and training in emerging Quality techniques and philosophy.
How do you evaluate the opportunities and challenges of Bangladesh pharma sector after its graduation from LDC?
It is indeed a seminal event in the history of Bangladesh that the UN has declared Bangladesh eligible to step up to a developing economy from being a Least Developed Country (LDC). In pharma sector, Bangladesh, like most other LDCs, can enjoy a comfortably long transitional timeframe to manufacture generic drugs until 2033. At this stage, Bangladesh should take the advantages of its LDC status and TRIPS waiver as much as possible. But the country is not going to sit that long with the LDC baggage to avail the benefit. If things move as predicted, Bangladesh will leave the LDC group by 2024. In order to sustain growth after its graduation, the industry will need to innovate and identify new opportunities. Bangladesh should start planning for post-graduation by framing a comprehensive Plan of Action for Graduation which will include progression towards innovation and TRIPS compliance. Bangladesh have to work on capacity building and institutional strengthening of its existing intellectual property and public health-related institutions.
Considering this paradigm shift Bangladesh should frame a National IP Policy and a National Health Strategy integrating long-term innovation and access objectives through the collaboration between universities, industries and government and public-private partnerships. The Government of Bangladesh may also approach the WIPO, WHO and IP offices of leading developing countries for technical assistance in dealing with TRIPS-compliant patent regime, particularly pharmaceutical patents. In this regard, the experiences of major developing countries like India, Brazil, China and South Africa are of vital importance, who have tailored their public health oriented TRIPS-compliant pharmaceutical patent regime by utilizing the TRIPS flexibilities and other governmental interventions in ways that do not conflict with the TRIPS obligations. Their strategic policy interventions though initially challenged by some WTO members and pharmaceutical MNCs but finally attained the international recognition as they have successfully defended their positions and subsequently followed by many countries. These flexibilities are also available to LDCs as they move towards TRIPS compliance.
Where do you stand in the global market?
Bangladesh is the only least developed country around the globe that meets up to 97% of its demand for pharmaceutical products, with a market size of nearly 2.5 Billion USD. Export Promotion Bureau (EPB) data shows that pharmaceutical sector exports to 199 countries which earned Bangladesh $103.46 million in the last fiscal year whereas it was $89.17 million in year 2017.
As it is very well known to us, HPL is making tremendous growth in the pharmaceutical sector in Bangladesh. For last 5-6 years, it is enjoying the highest growth rate in this industry. Where the (CAGR) for the last five years of the country's domestic pharmaceutical market is 15.6%, HPL is continuously holding its growth rate from 30-40% which is a very remarkable feat for this industry. Currently it holds the 4th position in the local market.
Despite its solid position in the Bangladesh Pharma Market, yet HPL have to run a long way to make its presence in the Global Pharma Market. Still our export sales are less than 10 million USD. If we make a ranking of the Bangladeshi companies that are doing well in export market, HPL is in the 9th position.
Global pharmaceutical market was approximately $990 Billion last year where HPL total sales including local and export was $140 Million which is very negligible. But we are trying to grow faster every year and we are progressing in international market at an average growth rate of more than 50%.
As an industry leader, how do you feel about the govt. decision to allow cash incentive in the export of finished products?
To encourage and boost up the pharmaceutical export sales of our local companies, government has decided to give cash incentive against the export volume. This will be applicable from the shipment of pharmaceuticals finished goods of fiscal year 2018-2019. This incentive will be calculated based on the FOB price of the products at a rate of 10%. This is a revolutionary decision in favor of our Pharmaceutical export sector because it was a long awaited decision that every pharmaceutical companies have been waiting for.
Previously, pharma industry was getting rebate facility based on the import amount of API and then again exporting it to any foreign country. But this amount was very small. So, it was a proposal from every pharmaceutical company to get cash incentive along with rebate facility to encourage the local investors to invest more on the export sector. From HPL we have given written proposal of granting 20% cash incentive every year as government was giving cash incentive to encourage export activities and build up business volumes to different sectors ranging from 5 to 20 percent. Finally, this decision has come in favor of us.
This decision will help to increase our export sales manifolds because:
R&D is very important to any pharmaceutical company. How much it matters to you?
Pharmaceutical companies are heavily reliant on research and development as their success is contingent on the development of new generic drugs. It plays a very important role in the success of a business. It is the R&D function that provides a platform for creativity and innovation to flourish in an organization. Innovative breakthroughs have happened only because of painstaking efforts of the R&D function. Perseverant efforts are needed when one is in pursuit of research.
Every year HPL R&D is developing more than 20 products for the local market also also taking good care for the international market too. Our annual R&D expenditure is almost 1 million USD.
In Bangladesh, the research & development (R&D) activities are mainly on formulation and to some extend in API. We should also start our R&D activities on drug development and new chemical entities. Bangladesh Government should come up with some incentive policy for this sort of venture, as it will not give revenue during initial few years to the company.
DGDA has launched a massive campaign to detect fake and date expired drugs. Do you think it is enough or awareness among the retailers and public is also needed?
To date, HPL’s exposure has been low; only a few cases of counterfeiting involving HPL products have been reported. We highly appreciate and fully support government efforts and is committed to cooperate with the authorities whenever a HPL product is concerned. Based on its corporate principles and recognizing the potential impact of this public health issue, we have added security features in our products to prevent counterfeits. We also have policy which ensures an action plan for rapid information, possible detection, coordination, analysis of suspect products, reporting and timely interaction with authorities.
However, these measures are not sufficient. Every company must also take responsibility to protect consumers and patients. Furthermore, it is necessary to raise awareness in the relevant institutions and authorities, educate the public and train local officials. Counterfeit and falsified medicines are mostly offered for sale by unlicensed sources. We should encourage buying medicines exclusively from trusted sources and licensed authorized pharmacies and health institutions.
Retail pharmacists (graduate, A grade pharmacist) can help dramatically reduce the use of fake or expired medicine to be dispensed to patients. Government should give more emphasis on role of graduate pharmacists in dispensing drugs to the patients in retail pharmacy and in the hospitals.
Without functioning of API Park, bulk of our revenues is drained out for import of raw materials. When do you expect API Park to start?
One of the major challenges for the country’s medicine sector is high dependency on imports for raw materials, which eats up competitiveness in the global markets. After completion of API Park, Bangladesh will be able to decrease the cost of locally manufactured drugs and get more competitive edge in the exports market. In addition, Bangladesh can earn from the $238 billion global market by exporting API.
According to BSCIC and BAPI, 27 API park plot holders started erecting facilities in the country's first drug industry API Park. Once completed, it is expected to meet almost 100% demand of the country’s medicines. The government should concentrate on speedy completion of the API Park utility service like, gas, electricity and other auxiliaries’ as soon as possible to help pharma companies start production there.
Although, declared as a thrust sector, lack of clinical trial laboratory are standing on the way of BE Study, which in turn, is hampering exports. How would you like to address this issue?
To commence or starting the pharmaceutical export, product registration is the pre-requisite process. Whether it is non-regulated/semi-regulated or regulated countries, product registration is a must procedure. Depending on the countries regulatory position, different countries ask for BE studies now-a-days. As per EPB, Bangladesh is exporting to 199 countries and three fourth of these exporting countries are requiring BE studies for product registration. Rest of the countries are still happy with the comparative dissolution report only.
As BE study report is an indispensable part of the product dossier that we submit for product registration, pharmaceutical companies have to collect this report by conducting BE Study from overseas CRO as there is no active CRO in Bangladesh and it is really an expensive process to collect BE report. Every BE report usually cost 20,000 to 170,000 USD depending on the country’s regulatory position and product nature. Basically, this charge varies on the molecule nature, number of API in each product, nature of formulation, regulatory accreditation that the CRO have, quality of the report and also the hierarchy of the regulatory level of the respective countries.
As the manufacturer has to pay the registration cost of the products, this huge cost involvement in spending BE study affects directly on the product price of the export market. It’s not like that we have to spend for BE study only, while paying these regulatory or support related fees Bangladesh Bank also takes a huge percentage of tax from the local companies based on the service type. Consequently our product prices become higher than our competitor’s countries like China, India or Indonesia and every year we loose good amount of export revenue of this sector. So, actually we are losing money in two ways.
Conducting BE in other countries and paying the fees, by this way we are transferring remittance to other country.
So, it’s quite understandable how we are suffering because of not having BE Center/CRO in our country. For the last 10-12 years, we are outsourcing the BE, studies from overseas countries like India, China, Philippines, Thailand or Vietnam. More than $250 Million sales in export market is not very little amount. So we should take proper step to establish some good quality CRO in our country. It may not be possible to establish bunch of CRO at a time but we can definitely go step by step. If we can do this in a joint venture with a foreign CRO company and investment comes from both companies, it can be a successful project, because foreign investor will look for utilizing every possible ways to make this sector profitable.
Another burning issue is Pharmacovigilance. How your company plans to promote Adverse Drug Reaction (ADR) Reporting?
Pharmacovigilance actively started in 2013 in Bangladesh and a guideline was prepared in 2018 by the Directorate General of Drug Administration (DGDA). The launch of the guidelines is an excellent initiative of DGDA to ensure uniformity in the execution of safety and effective monitoring of pharmaceutical related activities and health products in Bangladesh.
According to the DGDA, since 2013, it has got only 2,543 adverse drug reaction reports, including 740 in 2017, 665 in 2018 and 340 until June 30 in 2019. Statistics reveal that the reporting of the adverse drug reaction is still largely ignored in Bangladesh. But HPL has taken lead and as a compliant company we are running our own pharmacovigilance system in active stage. Our HPL PV team is working 24/7 round the year and maintains a dedicated contact number & e-mail address for reporting ADR & PQC. HPL PV team is actively engaged with Adverse Drug Reaction (ADR) capture, case processing, preserving ADR data for 2 years after reporting, Monthly Reporting & Submission to DGDA, Product Quality Complain (PQC) receiving & submission to QA dept. of HPL plant, Post marketing survey, Literature review and WHO PV newsletter monitoring, providing training on PV to our sales colleagues as well as head office colleagues, effective liaison maintenance with DGDA and other stakeholders, promoting awareness in Doctors, Patients and sales colleagues regarding ADR etc.
Do you have any plan to go for manufacturing of high-tech and import substitute products like anti-cancer, HIV/AIDS, Hormone and other life-saving drugs?
Through cutting-edge science, medicine and technology, HPL has continually evolved to develop and deliver the innovative medicines – shaping new ways to help patients prevail over serious diseases.
HPL has already established the first US FDA guided Oncology Plant in Bangladesh. This facility is a world class, state-of-the-art and dedicated Oncology manufacturing unit with high-containment processing and testing facility (with 100% Isolators) under consultancy support by an Australian company (APC) for the manufacture and supply of oral solids & injectable products for both local and international markets. The site is now under quality surveillance of globally reputed Lachman Consultant -USA, and ready to offer a new Onco-facility for interested partners in business in US markets. We strive to advance the frontiers of cancer therapy producing high-impact medicines for cancer patients.
Very soon HPL is going to introduce Hormone Unit which has utilities, equipment and proven technology suitable for most reliable, safe & efficient handling of products. The desired Operator Exposure Limit (OEL) is considered to be OEB – 5 using containment facility with isolation technology. HPL Hormone Facility has the capabilities to provide a comprehensive toll manufacturing service excellence supported by research and development in advanced technology, analytical service, formulation development, manufacturing for clinical trials as well as commercial production of our products.
In the coming years, the biggest story around HPL will be our contribution in delivering best quality high-tech medicines to patients. HPL is evolving exactly into what patients need in future.
Are you going to have any global accreditation in the near future?
From its inception in Bangladesh pharmaceutical market, HPL is well known for its excellent quality in its every single product. One of the quality symbols that HPL maintains is the manufacturing of a single product from the same manufacturing unit and distributing it on the local and export market. Not every company does this practice in Bangladesh. HPL is always starving for GMP accreditation and every year one or two GMP audits are take place is this company. Currently HPL is holding two Global GMP accreditation, one from NPRA, Malaysia and another one is TGA, Australia (just waiting for certificate). These two certificate is a PIC/S standard certificate which is also accepted by many other regulatory authorities across the globe.
Apart from this we have some others country specific GMP accreditations like;
In 2020, we are planning to conduct EU-GMP audit in our oncology facility which will be followed by ANVISA Brazil and US-FDA audit in the next year. We are also preparing for HSA, Singapore and Turkish-GMP audit for the MDI & Sterile facility by 2021.
Healthcare Pharmaceuticals Limited (HPL) encourages the healthcare professionals and every individual to report adverse events or safety issues, if any. If you come across any adverse event with HPL products, please report immediately at drugsafety@hpl.com.bd or call at +88019 9200 0175 or fax at +880 2 963 2172
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