The Government of India contrives to amend the Drugs and Cosmetics (D&C) rules to assure availability of medicines at reasonable costs and use of generic medicines, the finance minister (FM) proclaimed in the union budget for 2017-2018.
New rules will be designed for medical devices, which will help in optimizing the prices of such devices. “It’s a clear message from Govt. Of India that they putting efforts to amend the medical devices rules as to harmonize international standards and attract more investment into the sector”.
Initiatives from government has already brought for instance coronary stents under price control and demanded National Pharmaceutical Pricing Authority (NPPA) to set its ceiling price. This step has been met with resistance from the producers of medical device in the country.
Industry Fact Sheet:
- The Indian Drug Industry globally ranks 3rd in terms of volume and 13th in terms of value. The lower market share in terms of value can be imputed to the predominance of generic products which command lower prices.
- Drug manufacturing outsourcing to grow over 43% annually, thrice the global growth rate.
- According to few recent industry surveys, the national market size of Active Pharmaceuticals Ingredients (API), formulations and Contract Research and Manufacturing Services (CRAMS) is estimated at about USD 21.50 billion and the export market for the same is estimated at about USD 16.9 billion.
- India’s drugs and pharmaceutical exports have increased by about 60% during the last 5 years and accounted for about 54-58% of the total industry sales during FY16 compared with around 40-45% during FY11.
- The Indian drug production outsourcing industry to grow over 43 % annually, thrice the global growth rate, estimations from E&Y also E&Y, points, “Most of the top multinational pharmaceutical companies prefer only 10-15 established Indian industry players for drug manufacturing; going forth the global companies align with the 2nd and 3rd tier of Indian drug manufacturing companies”.
- Export market has grown at a CAGR of about ~10% in the past 5 years ended FY16; this can be attributed to a growing trend in outsourcing of pharmaceutical production by global pharmaceutical companies to low cost destinations like India and increasing penetration of generic drugs in the regulated markets on the back of patent expiries in the regulated markets.
- The Indian Drug Industry is expected to grow at a compounded annual growth rate of about 15% from USD over 36 billion in 2016 to USD 55 billion by 2020 given the huge export potential coupled with steady growth in the domestic formulation market.
Also, “The Medical Council of India (MCI) in the recent past had amended its guidelines to encourage doctors to prescribe generic names of medicines. In the finance minister budget speech, it has been signaled that changes may also be brought in to the Drugs and Cosmetics (D&C) rules along similar lines.
The Government of India also prepared an action plan to winnow out
- Elimination of Kala Azar,
- Elimination of Filariasis – 2017
- Elimination of Leprosy – 2017
- Elimination of Measels -2020
- Elimination of Tuberculosis B by 2025 has also been targeted
Industry specialists who track the sector say that Finance minister statement tips at government intent in making generic prescribing compulsory. It is usually thought that many medical practitioners preponderantly prescribe mostly those branded medicines, which are drug companies pushed even when a low-cost generic product is available in market. Even so, doctors maintain that to get the best possible result, medicines of the highest quality and best potential pharmacological properties should be prescribed to patients, and they usually prescribe drug brands that meet these measures.
In the meantime, the Indian government has been trying to make medicines so possible to buy and is recommending doctors to prescribe generic products as far as possible. To make prices cheaper the government is including more products into the National List of Essential Medicines (NLEM). The big Indian generic players who are confronting intense market competition and pricing pressure in domestic market are worried.
These will be a significant change if brought in our market, the pharma industry will have to change their marketing strategies going forth also there is no positive responses from industry analysts since they think, “these are not a good choice for now, since the doctors are more qualified and highly pertained about their patient over a chemist who makes the decisions based on the brand that gives highest profit base to them”, also if we compares to generic medicines of United States America, the FDA ensures products that were sold in USA maintain uniform quality standards however in our country, the inequality in terms of quality motleys significantly from one drug supplier to other, before these new initiatives comes into force Government of India should be ready with better more policies, there has to be stringent vigilance programs as to give high quality medicines to patients.