Friday, March 6, 2020

Pharmaceutical Industry in India Essays

Pharmaceutical Industry in India Essays Pharmaceutical Industry in India Essay Pharmaceutical Industry in India Essay Industry overview Pharmaceutical sector is an important industry of any modern day economic power. Pharmaceutical industry in India has a very humble past. After independence, development of pharmaceutical industry was one of the top agenda of government along with steel and manufacturing industry. The market was protected against competition for a long period of time by giving incentives to small firms, license-raj etc. Today the Indian pharmaceutical industry is the front-runner science-based industries in the country. Today the industry boasts of wide ranging capabilities in the complex field of drug manufacture and technology. The sector is pegged to be worth US$ 7. 3 billion. The annual growth rate is estimated to be around 13%. Reports suggest that the domestic retail market would be worth around US$ 12 billion by 2012. Indian pharmaceutical industry ranks 4th in terms of volume globally and 13th in terms of value. It has 8% share in global sales 20%-24% share in production of generic drugs. The domestic players satisfy almost all of the country’s demand for formulations and bulk drugs. Indian firms aren’t limited to domestic market; they are now competing head on with multi national players in international arena. For many firms, exports constitute 60%-70% of the total revenue earned. Reasons for this strong growth are low cost of manufacturing, low cost of RD, innovative scientific manpower etc. The total pharmaceutical exports in 2007-08 clocked US$ 6. 68 billion against US$ 5. 73 billion in 2006-07 recording a growth rate of 16 per cent. India is poised to be one of the fastest growing pharmaceutical markets in the world. This has led to entry of many major companies in the Indian market and a huge amount of FDI inflow. Evolution of the Indian Pharmaceutical Industry The Indian regulatory system made several arrangements to protect the domestic pharmaceutical industry from foreign competition in its nascent phase. One of them was recognition of only process patents. This built a sound and strong base for strong and competitive domestic market but deterred entry of foreign players. The life of Indian pharmaceutical industry can be broadly divided into two phases, namely Pre-Patent regime and Post-Patent regime respectively. Lets take a look at both of them in detail: Pre-Patent Regime: This period can be segmented into various time periods for better understanding: 1947-1970 During this period country was trying to stand on its feet after gaining independence. The pharmaceutical industry had to be built from scratch. Though several domestic players had sprung up in market but their impact on market was limited. The reason was their inability to compete with MNC players who had better access to resources, better technical know how and access to larger amount of funds. These foreign players imported formulations and sold them in India. They were neither contributing to pharmaceutical industries nor to the manufacturing industries in India. People had low spending and restricted access to healthcare facilities because of low levels of income. The government had realized that dependence on imported drugs had to be reduced so that essential drugs could be made available to public at cheap prices. For this country needed to build indigenous drug production capabilities. To fulfill this objective Hindustan Antibiotics Limited (HAL) and Indian Drugs Pharmaceutical Limited (IDPL) were setup in 1954 and 1961 respectively. These companies soon established themselves as major producers of critical drugs, which, were being imported at that time. 1970-1979 The MNCs continued to dominate the domestic market in spite of steps taken by government. Government introduced two legislations in 1970 to accelerate the process of self-reliance and indigenization. These were Indian Patent Act and Drug Price Control Order (DPCO). These two regulations provided the launch pad for the Indian pharmaceutical industry to take off into a new growth spiral. Indian Patent Act: The act granted patents only for methods and processes used to manufacture the substance. This allowed the domestic players to reverse engineer the drugs present in market and find its constituents. They started making the product using the same bulk drug by using a modified production process. Drug Price Control Order: Government regulated prices of 354 essential bulk drugs and formulations to ensure wide spread availability of drugs at a reasonable price. These two legislations changed the industry structure and growth pattern. Several small-scale ndustries (SSI) came into existence in formulation business. They had significant advantage as their products were out of purview of price control. Low entry barriers, abundance of bulk drugs and dispersed market acted as additional catalysts. All these factors had a significant impact on the position of MNCs in India. These regulations introduced the concept of price control did not recognize product patents. Therefor e the MNCs had no incentive of introducing new drugs in the market. Their overall share in formulations started to decline as time progressed. 1979-1987 Government in 1979 amended DPCO. Number of drugs under purview of DPCO was bought down from 354 to 163. Government also increased the permissible mark-up on drugs from 40%-60% to 75%-100%. DPCO also regulated the production by fixing ratio between formulation and key bulk drugs. This ensured continuous and uninterrupted supply of key bulk drugs. Investments made by government in past had started bearing fruit. IDPL and HAL provided technical assistance to smaller players in establishing their foothold. Hence even smaller players started to supply critical drugs to market. Indian firms started to invest in RD because of availability of skilled researchers in country. This resulted in launch of new drugs through process re-engineering. Government funded Central Drug Research Institute (CDRI) and Council of Scientific and Industrial Research (CSIR) made major contribution to the research base. Indian firms had advantage of low cost structure and very good reverse engineering technical skills. After they had established themselves in domestic market they turned their attention towards export. They took measures to utilize their advantage in global arena and were quite successful. There was no improvement in conditions of MNC’s. High tariffs caused the prices of their product to go up. Price control measures taken by government directed them to sell at cheaper price. Therefore they focused on specific sectors where they still had a stronghold. They were reluctant to launch new products in country because of lack of proper patent protection. This resulted in overall decline of their market share. 1987-1994 This was a consolidation period of the industry. The entire industry registered a double-digit growth rate through the period. This high growth rate was attributed to rise in per-capita income of people and introduction of new drugs at cheap price. The increase wasn’t limited to domestic market. While bulk drug production grew at CAGR of 16%, bulk drug export grew at CAGR of 40%. By 1994 exports comprised 50% of total bulk drug production. To meet the ever-increasing demand, companies had to invest heavily in increasing their capacities. High growth rate also attracted new players to the market. Competition in market increased manifold as the number of players in the market doubled over this period. Most important development of this period was liberalization program initiated by the government. The tariff barriers were lowered which leveled the playing field for MNCs vis-a-vis domestic players. This also increased foreign investment in domestic pharmaceutical industry. The liberalization policy also benefited domestic players who made efforts to increase their global presence due to lower tariff and non-tariff barriers. 1995-2001 The major development of this phase was government’s commitment to recognize product patent regime after 2005. This increased the expectation of MNCs. Most of them increased their equity stakes in Indian operations. MNCs also realized that they could convert India into their manufacturing base. India had quality manufacturing facilities at cheap costs. Domestic firms too had saturated Indian market. They were focusing on global markets more seriously now. They entered into alliances with MNCs, entered into JV’s in overseas market, set up world-class manufacturing facilities and strengthened their brands to strengthen their position. The small players finally came of age and gave serious competition to their bigger counterparts. Even though market grew at 15% intense competition from smaller players pushed the bigger players towards generic formulations. Bulk drugs had lower margins because of intense competition. To overcome this most players forward-integrated into formulation manufacturing or increased their export to non-regulated markets where margins were higher. 2001-2004 During this period domestic players increased their focus on market of generic drugs. They invested in RD and upgraded their manufacturing facilities to comply with GMP norms. During this period the domestic formulations market registered a decline, barring a few segments. MNCs were strengthening their interest in domestic market as product patent regime was to be implemented in 2005. Post-Patent Regime 2005-2006 Government passed an ordinance in 2005 implementing the product-patent regime. This move was aimed at bringing India at par with global pharmaceutical market. Other major developments during this period were implementation of VAT, shift in excise duty levy to MRP based levy and implementation of good manufacturing processes. During this period Indian players established themselves in global market with their innovatively engineered generic drugs API. 2006-2007 The new pharmaceutical policy has been center of attraction. Government wanted to bring essential drugs on which the manufacturers made fat profits under the purview of DPCO. The proposed pharmaceutical policy was aimed at bringing 354 essential drugs under purview of DPCO so that they are within reach of common man. The policy has provision of limiting MAPE to 150% to put a cap on profits earned by pharmaceutical firms. The duties on API were reduced to encourage manufacturing. Government has also set up NPPA to regulate pricing of drugs in India. Companies will have to sell their drugs at price decided by NPPA. Regulatory Environments in various parts of the world Europe The European Medicines Agency (EMEA) is the apex body, which governs medicine industry in Europe. Scientific opinions of the agency are prepared by committees i. e. the committee for medicinal products for human use (CHMP), the committee for medicinal products for veterinary use (CVMP), the committee for orphan medicinal products for rare diseases (COMP) and the new committee on herbal medicinal products (HMPC). EMEA performs the scientific evaluation of the quality, safety and efficacy of medicinal products in EU. EMEA also coordinates the resources for scientific evaluation and assessment regarding products undergoing the mutual recognition procedure and the master files for plasma and vaccine antigens. EMEA also provides guidance for companies requesting scientific advice. It also provides scientific advice before the application of new marketing authorization for centralized and mutual recognition procedures. Scientific Advice Working Party (SAWP) does this task. In order to sell products in EU markets firm have to obtain a license. This license is granted by CHMP after it assesses the product in question. European Pharmacopoeia (Ph Eur) specifies the quality specifications for pharmaceutical preparations and their ingredients. Before submitting a Marketing Authorization Application (MAA) the firm is required to show the safety and efficacy of the medicinal product. To show this local clinical data should be generated for a new medicinal product. Thus it is necessary to conduct clinical trails before launching a product in EU. If the product has already proved safety and efficacy in some other country then a bridging clinical study is sufficient. The initial license granted to a firm has to be renewed after five years. The risk-benefit balance is revaluated. If the result of re-evaluation is positive then the firm is granted the license for unlimited period of time unless the competent authority decides otherwise. In cases of drugs that require long-term safety study, the license for unlimited period is usually granted after 2-3 re-evaluations. The EU pharmaceutical legislation is very extensive and robust. In order to ensure high quality and safe therapies it provides extensive rules and guidance on licensing procedures for medicinal products. USA Pharmaceutical sector in USA is regulated by the department of Health and Human Services. The apex regulatory body is US FDA, which enforces the basic drug and food legislations. When a drug manufacturer develops a new drug, first the drug is tested on animals. Then he obtains approval for human trials through Investigational New Drug (IND). The data collected through human clinical trials in IND and animal studies is used to file a New Drug Application (NDA). NDA is used to communicate to FDA about safety and effectiveness of the drug, high quality manufacturing standard for the drug and appropriate labeling of the drug. New drugs are developed under patent protection. This grants exclusive marketing rights to the developer of the drug. After expiry of the patent period, other firms can sell a copy of the drug. This copied version of drug is called as generic drug. In order to get approval from FDA to sell generic drugs, firms must file for an Abbreviated New Drug Application (ANDA). Generic drug sector became very lucrative because the manufacturers of generic drugs didn’t have to invest in costly animal studies and human clinical trials. Also the pharmacists were given the right to sell substitute generic drugs instead of a specific drug unless explicitly specified by the doctor. To get an FDA approval for their ANDA the firms had to ensure that their drugs contains the same amount of active ingredient as the original drug, it should be identical in dosage form, strength and administration method and manufactured under the same manufacturing standards as for the original drug. A Drug Master File (DMF) is submitted to FDA that contains almost all information related o the drug. Some information in the file may be of confidential nature. India In India both the central government and the state government share the responsibility of regulating the pharmaceutical industry. The Drug and Cosmetic Act and Drug and Cosmetic Rule are the legislations passed by the government in this regard. Through this legislation the government regulates import, manufacture, sale and distribution of drugs in India. The central government plays as the coordinator of policies like drug approval, clinical trials, setting up standards, controlling the quality of imported drugs etc where as the state governments see that the policies laid down by the central government are being implemented by the firms. The Drug Controller General of India (DCGI) co-ordinates all the activities involved. Pharmaceutical industry in India regulated on basis of price, patent quality. DPCO fixes an upper limit on critical formulations API. NPPA regulates the pricing of all the drugs manufactured or sold in India. A firm cannot price its drug on its own; it has to be approved by NPPA. NPPA has also put an upper limit of 150% on MAPE. If the firm invests heavily in RD then the limit is increased by 50%. In 1995 government had amended DPCO to limit the size of drugs under purview of DPCO to 74. After implementation of product patent regime government is mulling over bringing the number of drugs under DPCO to around 200. The Drug Cosmetic act specifies the quality standards to be met for any drugs that is manufactured, sold or distributed in India. Manufactures have to follow GMP in their manufacturing plants. FDI up to 74% is allowed on the automatic route in the case of bulk drugs, their intermediate Pharmaceuticals and formulations (except those produced by the use of recombinant DNA technology). The Government considers FDI above 74% for manufacture of bulk drugs on a case-by-case basis. It’s allowed only for manufacture of bulk drugs from basic stages and their intermediates. It also extends to bulk drugs produced by the use of recombinant DNA technology and the specific cell/tissue targeted formulations if it includes manufacturing from basic stage. Government had liberalization plans of increasing the FDI cap to 100% and making the process of investing more easily and investor friendly. The plans were not implemented because of political pressure exerted by the Left Parties on the government. Recent Developments Raw material shortage hits pharmaceutical firms Olympic games in China have put brakes on high-flying Indian pharmaceutical industry. In order to present its clean image before the world during the games, China has ordered to close various drug manufacturing units to prevent environmental degradation. This has caused a scarcity of raw material in India and has pushed up prices of generic medicines. Daiichi Sankyo buys majority stake in Ranbaxy Daiichi Sankyo Company, Ltd (Daiichi Sankyo) has bought majority stake in Ranbaxy Laboratories Limited (Ranbaxy) from the Singh family, the largest controlling shareholders of Ranbaxy. The deal is subject to regulatory approvals. This deal will allow Ranbaxy access to global markets that have been off-radar for the firm till now. Daiichi Sankyo is looking forward to gain a stronger foothold in a very fast developing Indian market as well as the base established by Ranbaxy in USA. Sun Pharmaceuticals gets USFDA nod for generic Depakote The USFDA has granted a final approval to Sun Pharmaceutical Industries Ltd for its Abbreviated New Drug Application (ANDA) for generic Depakote, divalproex sodium delayed release tablets. Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures. US Congress to probe FDA`s Ranbaxy case The US House Energy Commerce committee is investigating the FDAs stance on the Ranbaxy case. The committee is to probe FDAs handling on Ranbaxys imports. The committee will also probe whether FDA knowingly let unsafe medicine to enter US. Sun Pharmaceuticals Taro deal Sun Pharmaceuticals, offered $454 million, all in cash, to buy out an Israeli generics manufacturer, Taro Pharmaceuticals. The deal has not been completed as yet because of encountering several roadblocks. Taro Pharmaceuticals is an Israeli pharmaceutical firm with a global presence. By acquiring Taro, Sun is trying to enter the low-competition, specialized segments like dermatology and pediatrics. Taro’s large presence in the Canadian market is also an attraction for Sun. Key Features of quarter April-June FY09 Improvement in product and geographic mix: Higher contribution from exports (62%) for generics and higher proportion of CRAMS business (46%) were the key highlights of the quarter. Improvement in margins: led by higher overseas and CRAMS sales, a 5. 9% YoY depreciation in the Rupee v/s the USD and increased captive consumption from companies like Dishman, Lupin and Piramal Healthcare. Raw material pressure to persist in the near term: China’s decision to (i) shut down polluting plants around Beijing and (ii) restrict the movement of hazardous chemicals in view of the Olympics resulted in raw material shortages and a consequent increase in prices. A rise in crude oil prices resulted in increases in the price of API solvents and intermediates. Our interaction with a few companies suggests that raw material shortage may persist for the next one-two quarters. Depreciating rupee leads to MTM losses on Forex debt: A 7. % and 9% QoQ depreciation of the rupee v/s the USD and Euro respectively resulted in most companies declaring MTM losses on their FCCBs and foreign debt. Prominent among the losers were Ranbaxy, Jubilant and Cipla. GSK recently signed a deal with Aspen and Strides GSK Pharmaceutical has collaborated with Aspen through which it would have access to a portfolio comprising 1200 products and 450 molecules of Aspen and its JV with Strides. GSK would get these products approved in 95 emerging markets and distribute and market these as well, while Aspen will continue to market in Sub-Saharan Africa and other countries. Jubilant signs drug discovery pact with Amgen Jubilant Bosys Ltd. and Amgen Inc. , the largest US-based biotech company on Monday announced a drug discovery partnership. As per the deal, Amgen and Jubilant will collaborate to develop a portfolio of novel drugs in new target areas of interest across multiple therapeutic areas. Jubilant will develop early preclinical candidates emanating from Amgens early discovery efforts for an initial term of three years. Amgen will have responsibility for the subsequent pre-clinical and clinical development and commercialization. Amgen will retain / own the drugs developed under the collaboration with worldwide commercialization rights. Jubilant Biosys will partner in early-preclinical development effort from its state of the art Jubilant Research Centre Bangalore, while Amgen will pursue later stage pre-clinical and clinical development and commercialization of the drugs in global markets. The financial terms include a combination of research funding and success-based milestones paid to Jubilant during pre-clinical and clinical development for multiple projects undertaken by the collaboration. The total financial Milestone value is subject to successful development and commercialization of the portfolio of novel drugs. Glenmark`s molecule for Neuropathetic Pain to enter Phase I trials Glenmark Pharmaceuticals Ltd has announced that its candidate for Neuropathic Pain, Osteoarthritis and other Inflammatory Pain-GRC 10693 is entering Phase I trials. The company intends to develop GRC 10693, a cannabinoid-2 (CB-2) receptor agonist, in neuropathic pain as the primary indication. The molecule has been filed for Phase-I approval with European regulatory authorities. Biocon, Abraxis launches ABRAXANE in India Biocon Limited and Abraxis BioScience, Inc, a fully integrated biotechnology company announced the launch of ABRAXANE (paclitaxel protein bound particles for injectable suspension) (albumin-bound) in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy, ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). The Phase III clinical trial in the U. S. demonstrated that ABRAXANE nearly doubled the response rate, significantly prolonged time to progression, and significantly improved overall survival in the secon line setting versus solvent based Taxol in the approved indication. The Medical House ties up with Dr Reddys Labs The Medical House Plc, a drug delivery specialist has signed a non-exclusive development, licensing and supply agreement with Dr Reddys Laboratories. The agreement covers an initial five-year term of supply, within US, European Union and Canada, with an option for Dr Reddys to extend the agreement to the rest of the world, on mutually agreed terms, the company said in a filing to the London Stock Exchange. The duration of the agreement can also be extended by mutual agreement and the development costs associated with customization would be paid to The Medical House (TMH) in addition to reimbursement of all agreed external costs. Strides completes acquisition of Ascent Pharmahealth Strides Arcolab has completed the acquisition of controlling interest in Ascent Pharmahealth Limited (formerly Genepharm Australasia Limited), thereby making Strides the 4th largest Generics Company in Australia. Strides now holds 50. 1% stake in Ascent Pharmahealth Limited, an ASX listed company. At final closing in Sept ’08, Strides may own upto 55% in Ascent Pharmahealth Ltd. Shareholders have voted to change the name of Genepharm Australasia Limited to Ascent Pharmahealth Limited. Ascent Pharmahealth Limited will include the assets of Drug Houses of Australia [DHA] in Singapore, a wholly owned subsidiary of Strides Revenue in excess of US$90mn on a combined Performa basis. Lupin acquires Hormosan Pharma Lupin Ltd has acquired Hormosan Pharma GmbH (Hormosan), a German Sales and Marketing generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS). Hormosan, with total sales of Euro 6. 8mn for the year ended December 2007, develops, licenses and markets a range of generics in Germany. Hormosan has a complementary product portfolio with products in the Central Nervous System and Cardiovascular therapeutic segments. Hormosan has created a strong brand identity in the German generics market through its strong patient compliance message, essential for patients within the CNS sector. Besides strong key account management the company also has a successful in Regulatory team, Pharmacovigilance, Medical Information and Marketing teams. Aurobindo Pharma receives nod for 2 ANDAs Aurobindo Pharma has received final approval from the US Food Drug Administration (USFDA) for 2 ANDAs namely Ceftriaxone for injection USP 250mg, 500mg, 2g and Ceftriaxone for injection USP 10g pharmacy bulk pack. These are Cephalosporins under the Anti-infective segment. Lupin Pharma receives nod for Divaiproex. Sodium Tablets Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Companys Abbreviated New Drug Application (ANDA) for Divaiproex Sodium Delayed-Release Tablets, 125 mg, 250 mg and 500 mg from the U. S. Food and Drug Administration (USFDA). Commercial shipments of the product have already commenced. Lupin Divaiproex sodium delayed-release tablets are the AB-rated generic equivalent of Abbott Laboratories Depakote tablets. Depakote had annual sales of approximately US$ 803mn for the twelve months ended March 2008, based on IMS Health sales data. Dr Reddy`s lab to invest in Perlecan Pharma Dr Reddys lab has purchased holding of Citigroup Venture Capital International Mauritius Limited its nominees and IDBI Trusteeship Services Limited (the merged entity after its merger with The Western India Trustee and the Executor Company Limited) in Perlecan Pharma Private Limited. The Board of Directors of Dr Reddys Laboratories Limited at their meeting held on July 21, 2008 had approved this proposal aggregating to US$18mn. References: pharmaceutical-drug-manufacturers. com/pharmaceutical-industry/ thehindubusinessline. com/iw/2004/07/25/stories/2004072500401000. htm ibef. org/industry/pharmaceuticals. aspx www. indiainbusiness. nic. in/industry-infrastructure/industrial-sectors/drug-pharma. htm