Regulatory Development - India

Regulatory Environment

Drug policy is governed by the 1986 law, which has been modified a number of times. The regulation seeks to guarantee reasonable prices for essential and life-saving drugs and their quality, as well as promote indigenous capacity for satisfying pharmaceutical demand. The legislation provides the basis for quality protection, although adverse drug monitoring and similar initiatives remain under-funded and partially neglected. While the drug registration is centralised, licenses for manufacturing and sales are given by an FDA of each of the state governments, which adds layers of bureaucracy to the process.

Prescription-only drugs are listed in Schedules H and X, which are included in the Drug & Cosmetics Act. Schedule G drugs -- mostly antihistamines -- do not require a prescription, but must carry a warning label. Drugs listed in Schedule H, X and G cannot be advertised to the public. Schedule K medicines ('household remedies') can be sold in certain non drug-licensed stores, but only in villages that have fewer than 1,000 inhabitants. All drugs that are not classed as prescription can be sold as OTCs, although the OTC category is not legally defined.

The main regulatory body in India is the Central Drug Standard Control Organisation (CDSCO), under the auspices of the Department of Health, although a new authority is presently being created. The Central Drugs Authority of India (CDAI) has been designed to replace CDSCO, which has failed to keep abreast with India's booming pharmaceutical industry.

The CDAI will be larger than its predecessor but, most importantly, it will centralise some procedures from individual states, allowing significant efficiencies to be realised. The new body was first proposed in 2003 by the Council for Scientific and Industrial research, but has been beset by numerous challenges. The cost of forming the CDAI and the accompanying expansion of capabilities is estimated at INR3 crore (US$750,000), which will be covered by increased inspection and drug registration fees.

The CDAI will assume responsibility for regulation, enforcement, legal and consumer affairs, biotechnology, pharmacovigliance/drug safety, medical devices/diagnostics, imports, quality control, and Indian systems of medicine (ayurveda, yoga, naturopathy, Unani, Siddha and homoeopathy). States will continue to grant drug licences, but supervision of manufacturing will be transitioned to the CDAI over a five-year period. The senior role of the drugs controller general will be renamed as additional secretary with two additional drugs controllers to work under that person, one on Indian systems of medicine and the other on all additional issues. Currently, the drug controller-general of India (DCGI) is in charge of the approval of licences of specified categories of drugs, which include blood and blood products, intravenous fluids, vaccines and sera.

Due to significant expansion of the industry in recent years, in July 2008, India announced plans for a Department of Pharmaceuticals, which was due to become operational by November 2008. The main functions of the new branch of the government will be to promote the sector, both domestically and abroad; boost biomedical research activities; develop infrastructure; engender public-private partnerships; and oversee five state-owned drugmakers. However, we are disappointed that a framework to facilitate dialogue with the approvals agency and pricing body has not been put in place. Unless all three have harmonised objectives, the Department of Pharmaceuticals may well become another layer of bureaucracy.

Table: Responsibilities Of India's Department Of Pharmaceuticals

1. Drugs and Pharmaceuticals, excluding those specifically allotted to other departments.

2. Promotion and co-ordination of basic, applied and other research in areas related to the pharmaceutical sector.

3. Development of infrastructure, manpower and skills for the pharmaceutical sector and management of related information.

4. Education and training including high-end research and granting of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.

6 .International co-operation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.

7. Inter-sectoral coordination including co-ordination between organisations and institutes under the central and state governments in areas related to the subjects entrusted to the department.

8. Technical support for dealing with national hazards in the pharmaceutical sector.

9. All matters relating to the National Pharmaceutical Pricing Authority, including related functions of   price control/monitoring.

10. All matters relating to the National Institutes for Pharmacy Education and Research.

11. Planning, development and control of, and assistance to, all industries dealt with by the department.

12. Bengal Chemicals and Pharmaceuticals Limited.

13. Hindustan Antibiotics Limited.

14. Indian Drugs and Pharmaceuticals Limited.

15. Karnataka Antibiotics and Pharmaceuticals Limited.

16. Rajasthan Drugs and Pharmaceuticals Limited.

Source: Ministry of Chemicals and Fertilizers

Although regulatory conditions have improved, other problems remain, especially with patent protection, a marked lack of pricing transparency and strict price controls. The legality of a vast amount of generic medicines is questionable and a sizeable counterfeit market exists. According to recent reports, India is the source of about one-third of total counterfeit drug trade in Asia, with state and national governments increasingly being urged to address the issue as a public health problem.

In April 2008, the World Health Organisation (WHO) criticised India's pharmaceutical regulatory system for lacking independence, being under-staffed and insufficiently rigorous. The global body has recommended changes and a delegation from the Indian government is visiting Health Canada to learn best practices in approving new medicines, although in the Asia region, BMI places India above average for approvals process.

Additionally, one accusation that cannot be levelled against the DCGI is inactivity. In February 2008, the agency suspended the production licences of four of India's largest vaccine producers after they failed to meet good manufacturing practice (GMP) standards, following the recommendation of the WHO. Implying that the problems were significant, three of the companies -- BCG Laboratory, Central Research Institute and the Pasteur Institute of India -- have subsequently ceased operations. Only Haffkine Bio-Pharmaceuticals is upgrading its quality standards, which w expected to take six to 12 months.

Meanwhile, the WHO has called on India's state governments to prepare a database of registered pharmaceutical brand names, in a move that has been welcomed as a solution to the growing problem of misleading product labelling in India. The Ministry of Health and Family Welfare has noted a trend whereby pharmaceutical products continue to carry the same brand label, yet contain different ingredients. For example, following a significant reduction in the price of aspirin by the National Pharmaceutical Pricing Authority (NPPA), some pharmaceutical firms have allegedly switched to paracetamol, while maintaining the same product name on the product label. In light of such discrepancies, the states of Karnataka and Delhi have introduced procedures and a 'No Objection' certificate must be obtained from the registrar of trademarks when introducing a new product.

Pharmaceutical Advertising

Pharmaceutical advertising is regulated by the Drug & Magic Remedies (Objectionable Advertisement) Act, which bans advertising of certain conditions and misleading marketing. The Organisation of Pharmaceutical Producers of India (OPPI) and the DCGI's office have produced a joint Voluntary Code on OTC Advertising, with the OPPI also creating a Code of Pharmaceutical Marketing Practices. While there is no formal ban on medical advertising, prescription-only drugs are not advertised by the industry, which is a general agreement. However, the DCGI is considering issuing a formal notification regarding the practice.

Pharmacovigilance

The WHO has described the lack of adverse event reporting in India as 'alarming'. The New Delhi-based federal regulator employs only 25 staff members to cover the entire country, which has a population of approximately 1.1bn. In comparison, Sweden -- which has a population of 9.9mn people -- has 250-300 drug regulators with the same responsibility. Figures compiled by WHO indicate that as few as 5% of adverse events are properly reported 'in the best circumstances'. India is estimated at a mere 1%, which is among the worst in the world.

Recent Regulatory Developments

Authorities are in the process of modifying the legislation on OTC and cosmetics sales, which will allow retail through grocers and department stores. Presently, the bulk of OTCs are sold through chemists and drug stores, which jointly account for approximately 80% of the total market. Direct sales were the second main channel of retail, with sales through grocers allowed only in rural areas with fewer than 1,000 inhabitants.

During Q307, a group of international medical associations met in India and called for a regulatory pathway specifically for generic versions of biological drugs. The request followed a study that revealed existing rules for these types of products were insufficient, sometimes resulting in ineffectiveness and biological intolerance, putting patient safety at risk. Plans for a centralised pharmaceutical authority in India resumed in October 2007, following a delay in September.

In October 2008, the WHO was reported to have given the DCGI a five-month deadline to start complying with international standards, which have -- since November 2007 -- been based on a five-step qualification programme. The original deadline of the end of October 2008 has been extended following WHO staff consultations with the Indian delegation, with the WHO reporting satisfactory progress to date. The development will affect Indian vaccine manufacturers, as they require the WHO's approval for international purchases. Similarly, foreign producers of vaccines in India will not be able to export their products until the issues are fully resolved. Since the start of 2008, vaccine makers have not been approved by WHO and UNICEF, over concerns of inadequacies of the DCGI and the re-recognition issue with the regulator.

In September 2008, the WHO was once again objecting to Indian drugmakers incorporating portions of international non-proprietary names (INNs) into brand names. It says that the practice causes confusion for prescribers and dispensers, and can compromise patient safety. While BMI agrees with the WHO, it must be remembered that Western pharmaceutical companies are also guilty of doing this. In a letter to the DCGI, the WHO expressed concern over a trademark application made by Ahmedabad-based Cadila Pharmaceuticals. The drugmaker wanted to have exclusive use of the brand name Platin for its formulation of cisplatin, an anticancer agent. The problem is that the requested trademark is identical to the INN stem used for platinum-derived antineoplastic agents, i.e. platin. Accordingly, Cadila's product could easily be mixed up with both oxaplatin and carboplatin.

This is not the first time that WHO has drawn attention to this issue. Earlier this year, it objected to Prazole and Nanotaxel infringing on the INN stems of -prazole (antiulcer, benzimidazole derivatives) and -taxel (antineoplastics, taxane derivatives), respectively. However, it does not appear that any action has been taken by the DCGI. In 1993, the World Health Assembly of the WHO adopted resolution 46.19, which sought to prohibit the use of INN stems in trade names. Significantly, it was up to the regulatory agencies of member states to enforce this rule and devise appropriate policies. India interpreted this directive and drafted Section 13(b) of the Trade Marks Acts. While enlightened countries such as Sri Lanka have rigorously adhered to the WHO guidelines, many others have overlooked them or not applied them universally.

It is significant to note that some of the most popular medications available today contravene the INN rule. However, we do concede that their uses of INN stems are not as explicit as some of the Indian cases. For example, GlaxoSmithKline (GSK)'s Trizivir (abacavir + lamivudine + zidovudine) in part leverages -cavir (carbocyclic nucleosides) and AstraZeneca's Zestril (lisinopril) incorporates the last three letters of -pril (angiotensin-converting enzyme inhibitors). The fundamental problem with the INN system is that consumers strongly identify with brands and are sometimes reluctant to embrace generic names, which can be long-winded. Notable examples of genericised trademarks include Sellotape (cellulose-based, pressure-sensitive adhesive tape), Zipper (interlocking clothing closure device), and Aspirin (acetylsalicylic acid).

Table: The Different Names For Paracetamol
International Non-Proprietary Name (INN)	paracetamol
British Approved Name (BAN)	paracetamol
United States Adopted Name (USAN)	acetaminophen
Other generic names	n-acetyl-p-aminophenol, APAP, p-acetamidophenol, acetamol, and others
Proprietary names	Tylenol, Panadol, Panamax, Perdolan, Calpol, Doliprane, Tachipirina, Atasol, and others
International Union of Pure and Applied Chemistry (IUPAC) name	N-(4-hydroxyphenyl)-acetamide
Source: BMI Research

IP Regime

A leading representative of WTO states that India must update its patent laws to international standards to encourage and reward innovation. The change is virtually inevitable as the reform will benefit domestic drugmakers that are involved in R&D, as well as foreign players. If changes are not undertaken, investment in the country will fall, severely hampering economic development.

Table: History Of The Indian Patent System
1856	The Act VI of 1856 on Protection of Inventions based on the British patent law of 1852. Certain exclusive privileges granted to inventors of new manufacturers for a period of 14 years
1859	The Act modified as Act XV; patent monopolies called exclusive privileges (making, selling and using inventions in India and authorising others to do so for 14 years from date of filing specification)
1872	The Patents & Designs Protection Act
1883	The Protection of Inventions Act
1888	Consolidated as the Inventions & Designs Act
1911	The Indian Patents & Designs Act
1972	The Patents Act (Act 39 of 1970) came into force on April 20
1999	On March 26, Patents (Amendment) Act (1999) came into force from January 1 1995
2002	The Patents (Amendment) Act 2002 came into force From May 20 2003
2005	The Patents (Amendment) Act 2005
Source: Intellectual Property India (http://ipindia.nic.in)

At the heart of the issue is India's controversial patent law, or Clause 3d. The legislation is incompatible with Article 27 of the TRIPS agreement, which allows the patentability of all kinds of inventions, including chemical and pharmaceutical products, stating that 'patents shall be available for any inventions, whether products or processes, in all fields of technology ... patents shall be available and patent rights enjoyable without discrimination as to ... the field of technology.'

However, under Clause 3d, 'Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.'

The problem lies in the fact that assessment of 'efficacy' is almost impossible to perform at the time when patent applications are filed, according to the Association of the British Pharmaceutical Industry (ABPI). Therefore, innovation through incremental steps, which is the way the vast majority of advances in medical science have occurred, is stifled. Without protection for 'tinkered' compounds, further research will not happen.

Both domestic and overseas companies are campaigning for data protection; Indian pharmaceutical companies, such as Ranbaxy and Dr Reddy's, are increasingly investing in R&D, and would also welcome better patent protection. The proposal that is currently under review by the government has a number of conditions, which essentially means that protection will start from the time a new product is first registered in any country, whereas in other markets, data protection starts from the date that a specific country licenses the product. The three-to-five-year term that is under review compares with five years in the US and six to 10 years in European Union (EU) member states.

Deficiencies Of IP Regime

In the past, the Office of the USTR led the criticism against the level of IP protection for pharmaceuticals. The USTR was concerned that some aspects of the new Patent (Amendment) Act 2005 fell short, and that India failed to include any TRIPS-compliant protection for data submitted to regulatory authorities as part of marketing authorisation applications. In 2006, IP problems were estimated to have cost foreign companies nearly 80% of their rightful market share, or around US$3.5bn in damages.

In its 2007 'Special 301' review, the USTR listed India as a 'priority watch' country, justifying its decision on the grounds that existing laws still remain inadequate to protect undisclosed test data for use in pharmaceuticals and agrochemical products. The USTR is especially critical of the enforcement of patents granted under the 'mailbox' system. This refers to products for which patents proving novelty status were delayed while awaiting India's implementation of TRIPS. According to the USTR, the new Patent (Amendment) Act 2005 does not enable those with patents filed under this system to prevent generic drugs from being sold after the date when the patent is granted. In 2008, however, India remained a 'priority watch' country, not because of pharmaceutical issues, but instead due to piracy of books, music and other similar goods.

Patent Disputes

In December 2007, after assessing patent application 885/BOM/1999m, the Mumbai office granted patent number 204132 to Pfizer's Celzentry (maraviroc). Pending marketing approval, the company will be able to sell the product for the treatment of HIV/AIDS without the damaging effects of generic competition. The development is momentous because various Indian patent offices have turned down antiretroviral (ARV) patent applications in the last decade. For example, earlier in the same month, UK-based company GSK pulled its submissions for Ziagen (abacavir) and Trizivir (abacavir + zidovudine + lamivudine). It is believed that the drugmaker made the move after a failed attempt by Swiss rival Novartis to invalidate Clause 3d of the Patent Act, which says that patents based on incremental innovations can be granted only if they provide major therapeutic advantages over existing products.

While undoubtedly important, Celzentry is unlikely to become a bestseller in India. The drug currently costs INR1,260 (US$32) for a day's treatment, or US$11,680 annually. In a country where the average yearly GDP per capita is just US$3,700, few will be able to afford it. Moreover, prior to treatment initiation, each patient must undergo a pathological test -- Monogram Biosciences' Trofile assay -- a blood test that determines the tropism of a patient's HIV. Additionally, since Celzentry has to be combined with other drugs, uptake is expected to be extremely low.

Previously, in a highly controversial move, Swiss multinational Novartis sought to overturn India's IP laws after the local patent office decided to decline the patent for Gleevec (imatinib), Novartis' groundbreaking cancer treatment. The Indian authorities alleged that Gleevec is not entitled to protection because it is a new form of an existing treatment that was developed before the cut-off date. Novartis therefore failed to invalidate Clause 3d of the Patent Act.

In August 2007, the Chennai High Court dismissed a petition by Novartis to declare India's patent laws unconstitutional. The firm claimed that the legislation, which restricts the issuing of patents to products that provide more than 'incremental' improvements, contradicted international trade laws. However, the court rejected the challenge on the ground that it does not have jurisdiction of whether Indian patent regulations are in compliance with WTO rules.

In the meantime, Swiss pharmaceutical major Roche issued a lawsuit against domestic leader Ranbaxy Laboratories with the aim of preventing it from selling a generic version of the company's anti-viral eye treatment Valcyte (valganciclovir). Roche claims that any generic version of Valcyte will infringe its patent on the drug, which is valid until 2014. Sales of Valcyte, in combination with a similar drug called Cymevene (ganciclovir), reached US$321mn in 2005.

In January 2008, Roche also filed a patent infringement suit against Cipla, which had launched a generic version of Roche's Tarceva (erlotinib) in the Indian market. The move illustrates continued clashes of the international research-based industry with Indian generic players.

Counterfeit Medicines

In January 2008, India's Ministry of Health and Family Welfare launched a nationwide survey to establish the true scale of counterfeit medicines in the country. The results will be used to identify perpetrators and to improve measures against the practice, which has expanded despite the counterfeit-targeting Drugs and Cosmetics (Amendment) Bill 2005. A smaller investigation funded by the WHO and conducted by SEARPharm Forum (a group of South East Asian regulatory agencies) in late 2007 found that just 3.1% of pharmaceuticals in India were fake or substandard, with the figure viewed as inaccurately low. Indian exports are, in particular, susceptible to counterfeiting activities.

Some culprits are deliberate counterfeiters, faking the packaging and re-labelling chalk or another inert substance as a drug. Other perpetrators are, however, legitimate firms that are simply slack in their operations. Indeed, with a little more effort, they might make a bioequivalent copy. Sometimes the entire firm is operating to low standards and at other times rogue employees work after hours to make bespoke batches for criminal organisations.

In August 2008, the WHO's proposed changes to the definition of medicine counterfeiting angered the Indian pharmaceutical industry. Drugmakers and regulators have expressed apprehensions that the sub-continent will be labelled as a centre for sub-standard pharmaceuticals. However, BMI believes the change will ultimately benefit both medicine manufacturers from India and patients around the world.

Under the proposals, any 'false representation in relation to identity, history or source' will be considered a case of medicine counterfeiting. The problem with this new definition is that genuine Indian exports could be termed counterfeit if medicines intended for one country end up in another through the actions of smugglers. India is of the opinion that this meaning goes beyond the previous concept of 'safety, efficacy and quality' and that smuggled drugs should be considered as 'unregistered products'.

Despite the protest, it is likely that the new definition will be adopted, which will strengthen supply chains across the globe. In the absence of advanced tracking technologies such as radio-frequency identification, tightened controls on the production, export, import, distribution and retailing of pharmaceuticals will ensure that medicines are fully traceable via invoices and trading receipts. This will mean that patients will have more confidence in the drugs they take. Indian drugmakers will also see upsides as their products will be increasingly associated with the high production standards that the vast majority already meet.

India is continuously looking to improve its production of healthcare products, which did not meet Western standard until the last couple of decades. In late July 2008, the Central Drugs Standard Control Organization announced that it was planning to expand its definition of counterfeit drugs to include medical devices, diagnostics and active pharmaceutical ingredients.

Table: Anti-Counterfeiting Guidelines From The Organisation Of Pharmaceutical Producers Of India (OPPI)

Overt (visible) features

Covert (hidden) features

Design of packaging components

Other design components

Control of components

Incident management

Source: BMI

Pricing And Reimbursement

The body responsible for pricing in India is the National Pharmaceutical Pricing Authority (NPPA), which has been operational since mid-1997. The NPPA is responsible for fixing and controlling the prices of 74 bulk drugs and formulations under the Essential Commodities Act, although only a few OTC ingredients (such as ephedrine) are price controlled. While controversial, the authority cannot be accused of being static -- the NPPA holds price-fixation meetings every other month. The latest round of price cuts came in April 2008, as part of the populist 2008-2009 Union Budget, despite a cut to excise duty on all formulation products. Overall, price control covers around 40% of the total pharmaceutical market in India.

Given that a number of essential drugs are already imported due to their low profit margins at home, the move to include more drugs under the price-fixing system has potential to worsen access to products and put the local industry at a disadvantage. This would open the door to regional competition, especially from parts of South East Asia. Furthermore, industry sources claim the change may also encourage the counterfeit industry to the overall detriment of both legitimate pharmaceutical industry and public health.

The NPPA's price controls and opaque pricing mechanisms are a subject of long-standing criticism. The agency has been keen to keep prices as low as possible, and has been reluctant to award price rises in line with inflation. The profits of pharmaceutical companies are also limited to 8-13% of pre-tax sales. Industry players, and in particular multinationals, view such practices as a major barrier to market entry and have voiced their opposition accordingly. As of July 1 2006, the maximum retail price (MRP) of a drug sold in India includes local taxes. The NPPA has very little access to market information originating from retail outlets. Therefore, it relies on prices that drug companies give chemists. This is sourced by the market research firm ORG IMS Research, a joint venture (JV) between IMS Health and ACNielsen.

Nevertheless, public sector procurement policies appear to be working effectively, with median prices lower than the international reference price (IRP) based on surveys in five states conducted between 2003 and 2005. However, private pharmacy mark-ups of up to 500% on branded generics were found in a 2007 survey of Delhi's pharmacies, due to opaque controls on the MRP set by manufacturers, resulting in high prices when drugs were out of stock in the public sector.

The Indian government announced in November 2006 that the country's pharmaceutical industry voluntarily reduced the prices of 886 pharmaceutical products by between 0.26% and 74.50%. Medicines targeted for the cuts included anti-diabetic agents and antibiotics, as well as painkillers and anti-hypertensives. However, local sources decried the reductions, claiming that the list of formulations covered only approximately 10% of the market by volume and around 5% by value. Although the list included nearly 100 types of drugs, the leading brands were not included. This led to speculation that the pharmaceutical industry is merely negotiating with the government in order to prevent regulation on essential drugs, by offering some price concessions on its lowest-selling brands.

The Indian Ministry for Chemicals and Fertilisers subsequently claimed that pharmaceutical companies had 'cheated' over proposed price cuts. The industry reportedly failed to apply the formula that had been agreed upon with the government, warning that the authorities should not be considered 'toothless'. Although it is not known what action would be taken, there was speculation that some drugmakers could face some kind of penalty. It had been alleged that the pharmaceutical industry had agreed to the concessions in the first place in order to prevent further regulation of essential drugs, a strategy that now seems to have backfired.

Central VAT is 16.0% or 57.5% of the MRP. State VAT accounts for a further 4% of the drug price, with wholesale margins being around 10% of the MRP (excluding taxes). The final consumer price includes a margin of 20% of the MRP (excluding taxes). Price-controlled products have a retail margin set at 16% by the Drugs Price Control Order (DPCO). Both wholesale and retail margins are determined by the OPPI and the All India Organisation of Chemists & Druggists (AIOCD).

Recent Pricing And Reimbursement Developments

In April 2008, India's controversial National Pharmaceutical Policy (NPP) was nearing introduction, despite resistance from the drug industry. Under the plan, regulations will be toughened and more medicines will come under price control. Although these changes will ultimately benefit patients most, NPPs can have both positive and negative outcomes, as seen in other countries.

In July 2008, the Indian government was contemplating the collective purchase of all patented drugs and medical devices for the entire country to decrease overall costs. It is suggested that multinationals would benefit from a reduction of promotional expenses, although they are unlikely -- as a whole -- to be net beneficiaries. What makes this proposal even more unlikely is that some drugmakers, including GlaxoSmithKline and Merck & Co, are already selling patent-protected medicines at concessional rates in India. The news highlights the Indian government's efforts to control the rising per capita drug expenditure.

The NPPA's recent announcement of a series of price cuts of up to 36% on the prices of 16 drugs currently on the national essential medicines list, as well as its intention to cap, or even reduce, the maximum retail prices of more than 300 other drugs (including antibiotics, multivitamins, asthma and anti-malarials) does not bode well for manufacturers in the country. Additionally, an agreement was recently reached with the pharmaceutical industry that drugs on the essential medicines list should be supplied at a 50% discount on their official maximum retail prices.

The main thrust of the draft NPP is to increase the proportion of India's US$13bn medicine market under price control from the current 20% to more than 35%, essentially adding 354 drugs to the list of price-controlled medicines. Furthermore, there are plans to strengthen regulations covering trade margins, the public procurement of drugs, price negotiations for patented medicines and new medical devices, and pharmaceutical-related offences.

Table: Criteria For Rational Drug Use
Appropriate indication	The decision to prescribe drug(s) is entirely based on medical rationale and that drug therapy is an effective and safe treatment
Appropriate drug	The selection of drugs is based on efficacy, safety, suitability and cost considerations
Appropriate patient	No contra-indications exist and the likelihood of adverse reactions is minimal, and the drug is acceptable to the patient
Appropriate information	Patients should be provided with relevant, accurate, important and clear information regarding his or her condition and the medication(s) that are prescribed
Appropriate monitoring	The anticipated and unexpected effects of medications should be appropriately monitored
Source: Boston University Medical Campus (http://dcc2.bumc.bu.edu/prdu/Session_Guides/problems_of_irrational_drug_use.htm)

In December 2008, India's drug price regulator decided to increase prices of 31 medicine brands and lower prices of 46 brands. Around 254 new medicine brands will also be brought under price control, which will have a marginal impact on the overall drug market values. Various insulin brands and cancer drugs, however, will be more expensive after the new prices come into force.

Around the same time, the regulator revised the prices of 331 formulation packs based on 52 bulk drugs. Drugs subject to price revisions include multivitamins, potassium penicillin G, ranitidine and monocomponent insulin. Previously, the prices of vitamin C bulk drugs were under review, as these have nearly disappeared from the Indian market. Companies have stopped selling vitamin C medicine because the cost of raw materials has increased sharply in the last few months.

Geography: India

Channels: Pharmaceuticals & Healthcare

Source PDF: India Pharmaceuticals & Healthcare