Sakar Healthcare Ltd is evolving as a major contract manufacturing company catering to the specific requirements of pharma giants operating in India and abroad
Established in the year 2004-05, Sakar Healthcare Ltd is an emerging pharmaceutical company engaged in manufacturing pharma formulations. Sakar Healthcare is an ISO 9001:2008 certified company and its merits reflect in the long list of other certifications that it holds. Drug control authorities of various countries in South East Asia, Latin America, Africa and Middle East have acknowledged and certified the products. The company has evolved as contract manufacturing company catering to the specific requirements of pharma giants operating in India and abroad.
Over the past decade, Sakar has matured into a reliable manufacturing organisation, that not only caters to the requirements of the giants in the Indian and overseas pharma industry, but also manufactures products under its brand name as well as markets them through its sales and distribution network. Sakar manufactures and markets pharma formulations related to analgesic, anthelmintic, anti-coagulants, anti-malarial, anti-spasmodic, anti-anaemic, antibiotics, anti-emetic, anti-histamines, bronchodilators, corticosteroids, cough and cold preparation, multi-vitamin etc. Sakar focusses on quality, delivery schedule, adherence to standards guidelines and these efforts have resulted in number of brand registration internationally.
Sakar has a vision to become a global healthcare organisation based on three pillars- people, partnership and performance; making lives healthy happy and more meaningful by providing world-class healthcare solutions. It looks forward to strengthening the core competencies to become the preferred choice in existing partnerships and explore new market opportunities to expand its range of products and services- respecting laws, protecting environment and benefitting mankind. This would ensure the company’s presence in the arena of contract manufacturing as well as self branding and marketing of brands, for both international and domestic markets.
This transformation of Sakar Healthcare Pvt Ltd to Sakar Healthcare Ltd has set up a new milestone. It is now confident of having its plants EU-GMP approved in few months. On time service, quality assured products and most important, flexibility to meet the emerging market requirements are some of the salient advantages of Sakar over its competitors. To add on to the current facilities, Sakar Healthcare is coming up with a lyophillizer with auto loading/ unloading and orabs, to meet the increasing demand and ensure world standard formulations. Thereby Sakar Healthcare has transformed itself as a contract manufacturer with class. With 126 brands registered across the globe, Sakar Healthcare is emerging as a pharma company involved in functions like marketing and sales apart from contract manufacturing. For Sakar, selective partnerships with local players is the key to drive the overseas markets. This approach has firmed up a number of JVs which have started giving returns. Thus, Sakar Healthcare has actually got transformed to an overall pharma house involved in manufacturing and marketing operations in both domestic and international markets.
Contract manufacturing
Majority of the leading pharma companies are trying to outsource more and more manufacturing activities to contract manufacturers so that they can focus on core activities of drug discovery and marketing. There is a rapid rise in the pharma contract manufacturing organisations in India and China in recent years and this will further aid to the growth of the contract manufacturing industry. Though there is lot of potential for growth for the pharma contract manufacturers, this prospect comes hand in hand with the challenges, which contract manufacturers have to face to capitalise on the opportunity.
Contract manufacturers need to reinvent themselves for the challenges that lie ahead, from the traditional role of providing cost efficiencies, capacity, labour and machinery. They have to get ready to the face more complex process technology that would be required to manufacture new drugs. The challenges of stringent process control and increased automation will require further skills and new ways of working. Also, it is foreseen that speciality drug administration will have an element of information technology in it as controlled dosage would be required to be released at a targeted spot in patient’s body. Though the technical know-how will be supplied by the pharma, the contract manufacturers have to invest both in technology and people to meet this challenge. To achieve efficiencies and to beat the competition, contract manufacturers would have to invest in IT application in areas of ERP, MES and industrial automation.
Next big challenge will be adoption and implementation of Good Automated Manufacturing Practice (GAMP) that will help contract manufacturers to build in quality in every process step apart from having it in a batch of a pharma product. GAMP coupled with current Good Manufacturing Practices (cGMP) will yield better compliance of manufacturing installations, processes and related systems. Since the products are sold in global markets, it will be important for contract manufacturers to have quality system that meets the regulation of the various markets and of the pharma companies. Documentation compliance will be important as the process is evolved and confirmed during trials.
Contract manufacturers will have to invest in project management skills as project scope would be exposed to scope changes owing to manufacturing complexity and various trial manufacturing runs and subsequent revisions during lab to plant scale-up phases.
Procurement
Procurement is the acquisition of goods and/ or services, preferably at the best possible cost and / or value, and ensuring those goods are purchased in the right quantity and quality, at the right time, in the right place, and from the right source. The procurements in our organisation ranges from automated repeat purchasing of office supplies through a vendor punch-out to the complex procurement of custom manufactured goods which involves sourcing raw materials and components from dozens of domestic and global suppliers and ensuring that they all arrive at the manufacturing plant at the right time for finished goods production and distribution.
Over the years, Sakar has been able to identify and develop a database of vendors ranging from manufacturers to retailers for various goods and services being utilised at its facility. It has also developed an automated system of procurement and vendor management wherein the vendors are mapped to the products being offered by them, so that whenever a product is to be requisitioned Sakar has a ready list of suppliers who can supply the same at very competitive prices. This process helps in ensuring quality of material being delivered, timely delivery of material at the facility and competitive prices. The list of vendors is regularly reviewed and updated so that new suppliers are incorporated in the list and the suppliers who do not meet the quality requirements can be highlighted/ blocked. Sakar also has an automated system for ordering wherein as soon as the material reaches the marked minimum quantity, respective store incharge is intimated about the same and he can initiate the requisition process as per the production requirements or minimum order quantity so that materials are procured just in time to avoid inventory holding cost.
Material procured is subject to quality tests before including the same in the stores. Only those materials that satisfy the quality standards are included in the stocks and utilised for production of various pharmaceutical formulations. The processing of documents is taken care by respective departments through an integrated online system.
Site audits for vendor approval are critical for zeroing down on vendors for domestic market procurements. Site audits provides with an insight into the manufacturing facility of the vendors and also helps in understanding the quality standards implemented by the vendors in their manufacturing process and the quality of products manufactured and services offered. Pharma industry, being one of the highly regulated industries, has to comply with various regulatory requirements from the initial stages of manufacturing/procurements of API to taking approval from respective regulatory boards to sell the finished products i.e. the pharma formulations. In order to meet the various regulatory requirements for the quality of finished product, Sakar have ensure the implementation of similar quality standards from the very stage of acquisition of material for production and site audit provides the assurance that the company is on the right path from the very beginning.
Pharma is a highly regulated industry since it caters to the health of the human beings. The procurement of active pharmaceutical ingredient (API) is guided by the regulatory requirements of the country of manufacture and the market being targeted. API has to satisfy the regulations stipulated in the country of manufacture and also by the additional requirements of the sourcing country regulations e.g. an API manufactured in India to sell a final formulator, in say, US needs. The API will to be subjected to the regulatory authorities in India and the API manufacturer will have to produce it, at a minimum, with the quality standards enforced by the Indian authorities. However, the US can require that for importation, it meets US FDA standards as well. Irrespective of the markets, whether it is regulated, rest of the world (ROW) or domestic, API, which is being procured to cater these markets, have to comply with regulatory requirements of the respective markets. The only difference could be with respect to the number of compliances to be met in these markets. Though every market has to adopt and implement the minimum requirements prescribed by WHO, to approve an API for utilisation in manufacture of pharma formulation. Therefore, care has to be taken of the additional regulatory requirements of the target market in addition to the minimum regulatory requirements while procuring API for pharma formulations.
Trade shows
Today, trade shows provide a platform where manufacturers and customers get a chance to interact with other directly and understand each others requirements. It is a medium where manufacturers get a chance to display all their offerings at comparatively lower cost to the prospective customers. Manufacturers also get a chance to understand the requirements of the customers which helps the manufacturers to develop new formulations to cater the prospective demands.
In the year 2015, there are 124 pharma trade shows planned in 64 cities and 39 countries including 10 in India. Sakar plans to participate in as many trade fairs as possible so that it is able to interact with prospective customers of as many countries as possible and help penetrate regulated, ROW and domestic markets.