2015 was healthy growth for the Indian bio pharmaceutical industry repelled mainly by mergers and acquisitions, and with the rebounding of domestic pharmaceutical market growth. Then again, 2016 is assured as a year of hope further development encouraged by a better United States of America and domestic market of India, with many industrial policy decisions came up however still there are some challenges and issues in the domestic market which needs to be addressed very promisingly; policy wise India has a federal form of government, therefore the drug regulatory structure is parted between national and state authorities. Pharmaceutical products are regulated by Central Drugs Standard Control Organization (CDSCO) under Ministry of Health and Family Welfare (MOHFW). Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through Drugs Controller General of India (DCGI) at Chair. This update brings about trends @ Indian pharmaceutical industry also burning or major issues and describes the thought process for the error corrections.
Trends @ Indian pharmaceutical Industry
Firstly bulk drug policy:
To cut down India’s dependence on other countries especially from china, recent past the government of India has initiated with a bulk drug policy. Bulk drugs, or Active pharmaceutical ingredients (API), are the active raw materials or substances used in a drug production process.
Initiative from government gives boost to for public sector companies, tax-free status for producers and cluster development are likely to be the foregrounds of this new policy.
Secondly, compulsory marketing code:
A compulsory code is fixed to substitute the voluntary Uniform Code of Pharmaceutical Marketing Practices from Q2-2016. This will proscribe the practice of pharmaceutical companies providing gifts to medical practitioners reciprocally for prescribing products.
Thirdly, Online pharmacies:
Ordinance of the flourishing business of online pharmacies is also anticipated. Online pharmacies in India have significantly increased due to growing E-commerce in India. An online pharmacy is an Internet-based vendor of prescription drugs, and the term encompasses both legitimate and illegitimate pharmacies. Online pharmacies have been increasing in India, with the rise attributed to little regulation of the industry.
Legal status in India:
The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labeling and bar coding. It appears that electronic prescriptions should be valid especially in the light of the Pharmacy Practice Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these regulations, “Prescription” is defined by regulation 2 (j) ‘means a written or electronic direction from a Registered Medical Practitioner…….’ On basis of existing regulations it appears that a scanned copy of prescription will be perfectly considered as a valid prescription. However, whether such electronic prescriptions can be used to buy medicine from online pharmacies has been questioned.
Also cap on trade margins:
Trading margin is the margin which wholesalers and retailers earn by selling the medicines. A margin cap on generic medicines sold through distributors is anticipated very soon. India’s total pharma market in these products, known as trade generics, is nailed at Rs.5000-6000 crore. In trade generics, the pharmaceutical distributors charge medical representatives (MR’s) to sell medicines to medical practitioners in rural regions, in addition to distributing to retailers. The Prime Minister’s Office has stepped in on the issue as in some situations trade margins go up to 4,000%. For example, if a particular product is supplied to the distributor for Rs.1 by the manufacturer, its price can even go up to Rs.20 once it reaches the patients.
Major issues in Indian drug regulatory:
We have ordinance, rules of pharmaceutical products in India with evidently strong regulations and however weak Implementation. For example: at the patient level still there is miss use or self – prescription of the medicines, with or without a written medical prescription.
Also the procedures of ineffective products are very tough to deal therefore it become quite difficult to follow the considerations.
According to the various reports, “India is also listed by the Pharmaceuticals Security Institute [PSI] as one of the top 5 sources of counterfeit drugs 20 – 25 % (approximately) of medicines available in the country are sub-standard products.
Deficiency of regulatory expertise and testing centers which are needed to put through standards.
Missing limpidity on patentability and conditions of pharmaceutical substances under which pharmaceutical companies can apply for compulsory licenses which can forestall legal issues among national, multinational companies and civil rights groups and many more issues and challenges to write.
The drug industry is politically very sinewy and it has used all its influence in the past to close up reforms fathered by the Government.
- Consequence of poor drug regulations
- Substandard medicines are leading to negative health outcomes.
- Increased antibiotic resistance and many other issues
Policy designers and ministries should need to think for centralized licensing procedures because states lack the required resources to coordinate their operations among themselves, and this condition taken advantage by the many layers in the Indian pharma market channel (manufacturers, distributors / suppliers, retailers, patient’s even and other sources).