Antibiotics are losing their power

The Antibiotics are losing their potential strength to fight against the bacterial infections. The antibiotic resistance causes people to be sick for longer and increases the risk of death.

The reason of the antibiotic resistance is unwanted consumption of the drugs without prescription of the medical practitioner.

DO NOT USE ANTIBIOTICS WITH CONSULTATION OF THE PHYSICION

This issue is becoming critical in each country.  There is a possibility that the antibiotic resistant bacteria will be known as a global killer of the human race.

As per World health organisation, the resistance of the Antibiotics is a major threat to human being.

What is meaning of antibiotic resistance

When the antibiotic is not able to kill/prohibit growth of bacterial because of the genetic modification of the bacterial cells.

What is an antibiotic?

A: Antibiotics, also known as antimicrobial drugs, are drugs that fight infections caused by bacteria in both humans and animals. Antibiotics fight these infections either by killing the bacteria or making it difficult for the bacteria to grow and multiply. Antibiotics only treat certain bacterial infections. Antibiotics do not have any effect on viruses.

The antibiotic resistance means that the antibiotics cannot be used as to treat the bacterial infection and there is a need to use more potent antibiotics.

As per World health organisation:

The antibiotic/antimicrobial resistance is happening across many different infectious agents.

There are major 7 kind of the antibiotic resistance found in different bacteria which are responsible serious diseases like diarrhoea, bloodstream infections, gonorrhoea and pneumonia, urinary tract infections

How to fight against antibiotic resistance?

1.     Social education by government

2. Use the antibiotics only as per prescription of physician.
3. When you are prescribed antibiotics, take the full prescription even if you are feeling better. Ensure that members of your family do the same.
4. Never share antibiotics with others or use leftover prescriptions
5. Tell your healthcare professional you are concerned about antibiotic resistance.
6. Take the prescribed antibiotic exactly as your healthcare professional tells you.
7. Safely throw away leftover medication.
8. Ask your healthcare professional about vaccines recommended for you and your family to prevent infections that may require an antibiotic.
9. Never skip doses.
10. Never take an antibiotic for a viral infection like a cold or the flu.
11. Never pressure your healthcare professional to prescribe an antibiotic.
12. Never save antibiotics for the next time you get sick.
13. Never take antibiotics prescribed for someone else.

How Healthcare professional can prevent the spread of antibiotic resistance:

• By prescribing an antibiotic that targets the bacteria that is most likely causing their patient’s illness when an antibiotic is likely to provide benefit.
• Encouraging patients to use the antibiotic as instructed.
• Social awareness to each patient

MEXICAN HEALTH AUTHRITY (COFEPRIS) GUIDELINE

MEXICAN HEALTH AUTHRITY (COFEPRIS) GUIDELINE

The Mexican halth authority guideline is not much popular in the pharmaceutical sector compaired to the other regulatory agencies guidelines. 

The Mexican heath authority which is called as COFEPRIS. The full form of the COFEPRIS is “Comisión Federal para la Protección contra Riesgos Sanitarios”.

COFEPRIS is an official organisation of the Mexican government. This agency is founded to monitor and control manufacturing and import of the health products. 

The health products include Medicinal finished dosage forms, active pharmaceutical ingredients, organ transplants etc.

The COFEPRIS authority has their own guideline to approve the drug product manufacturers and active drug manufacturers.  

The applicable COFEPRIS guideline are-

NOM 164 SSA1 2015: - This guideline is applicable for the active drug manufacturers like API, drug products in the form of semi-finished goods like pellets, DC powders.

NOM 159 SSA1 2016: - This guideline is applicable to the manufacturers of the finished products like tables, capsules, ointments, medicated creams etc.

These both guidelines are having very minor difference in the contents. The COFEPRIS guidelines are much more focused on the risk assessment on all the quality management functions.

The contents of the Mexican health authority guideline (NOM 164 SSA1 2015) are descried below-

0. Introduction.

1. Objective and field of application.

2. References.

3. Definitions.

4. Symbols and abbreviations.

5. Quality Management System

6. Quality Risk Management.

7. Personnel

8. Facilities and equipment.

9. Qualification and Validation.

10. Production systems.

11. Quality Control Laboratory.

12. Product Recall

13. Outsourced Activities

14. Destruction and final disposal of waste

15. Distributors

16. Manufacture of drug substances for use in clinical studies.

17. Compliance with international and Mexican standards.

18. Bibliography

19. Observance.

20. Validity. 20.1 Normative appendix A. Manufacturing areas classification.

20.2 Normative appendix B. Annual Product Review

The contents of the Mexican health authority guideline (NOM 159 SSA1 2016) are descried below-

1. Objective and application field.

2. References.

3. Definitions.

4. Symbols and abbreviations.

5. Quality Management System.

6. Quality Risks Management.

7. Personnel.

8. Facilities and equipment.

9. Qualification and validation.

10. Manufacturing systems.

11. Quality Control Laboratory.

12. Finished product release.

13. Market Product Recall.

14. Subcontracted activities.

15. Wastes Final Destination.

16. Good Storage and Distributions Practices.

17. Agreement with international and Mexican standards.

18. Bibliography.

19. Compliance.

20. Validity

21. Appendixes.

21.1. Normative Appendix A. Manufacturing Areas Classification.

21.2. Normative Appendix B. Product Annual Checking.

Optimus- Unichem Merger

The domestic Pharmaceutical leader “Unichem Laboratories” disclosed that the company has acquired 19.99% shares of the each in 2 API (active pharmaceutical ingredient) manufacturing unit of Optimus pharmaceutical.

The optimus pharma is a Hyderabad-based pharmaceutical group which has total revenue of Rs 120 crore ($16.5 million).

As part of the transaction, the firm bought stake in Optimus Drugs Pvt. Ltd for Rs 72.08 crore and acquired holding in Optrix Laboratories Pvt. Ltd for Rs 47.92 crore, Unichem said in a stock market disclosure.

The acquisition will give Unichem access to the active pharmaceutical ingredient (API) facilities of the two companies in Hyderabad and Visakhapatnam. The deal will also provide the acquirer with additional capacity to fulfil its export orders.

Optimus, founded by D Srinivas Reddy in 2004, had a total income of Rs 198.86 crore for the financial year ended March 2018, said the stock market disclosure. Optrix, which was set up in March 2012, reported a total income of Rs 173.38 crore for the financial year ended March 2018, said the disclosure.

Both the companies, owned and controlled by the same management, are engaged in researching, developing, manufacturing, marketing, and distribution of APIs and intermediates.

Trans-Continental Capital Advisors Pvt. Ltd and Genesis Management Consultancy Services Pvt. Ltd acted as financial advisers to the transaction.

Unichem

The company, founded in 1944 by the late Amrut Mody, is known for its speciality pharmaceuticals business. The drug maker has more than 500 regulatory filings for APIs.

In its latest annual report, Unichem said that it intends to ramp up its capabilities and capacities in APIs and intermediates manufacturing to serve its fast-growing US formulations business.

“The opportunities in the API space are growing, with branded drug sales coming off patent and an increasing number of successful patent challenges made by generic companies,” it added.

Unichem reported total revenue of Rs 879.4 crore for the financial year ended March 2018, up from Rs 704.17 crore a year earlier, going by the company's filings to a stock exchange.

Unichem Laboratories has entered into an agreement to acquire 20 per cent stake in the Active Pharmaceutical Ingredient (API) and intermediate business of Hyderabad-based Optimus group. The financial terms of the deal were not disclosed.

The transaction will give Unichem access to Optimus’ US Food and Drug Administration approved API manufacturing facilities, while Optimus will benefit from the knowledge base and industry best practices of Unichem, Unichem Laboratories said in a statement.

Trans-Continental Capital Advisors and Genesis Management Consultancy Services were the financial advisers to the transaction.

Pharma firm, Unichem Laboratories announced that the company has entered into an agreement to acquire 20 percent equity stake in the API and intermediate business of Hyderabad based Optimus group.

The acquisition value is Rs 120 crore, a company statement said.

The transaction will give Unichem access to Optimus' US FDA approved API manufacturing facilities, and at the same time, Optimus will gain from the extensive knowledge base and industry best practices of Unichem, making the deal a win-win for both Unichem and Optimus, the release said.

Unichem engaged in speciality pharmaceutical business manufactures and markets a large basket of generic pharmaceutical formulations in several regulated markets across the world. The company has deep expertise in research, product development, process chemistry and manufacturing of complex API as well as dosage forms.

The Optimus group operates as manufacturer of formulations, API's and intermediates for Indian and other regulated/RoW markets. Presently, the group's API vertical has its manufacturing facilities located in Hyderabad and Vishakhapatnam, having specialisation in novel/polymorph chemistry and process engineering.